Proven Gen-Flex Revision Knee System. Surgical Protocol

Transcription

1 Proven Gen-Flex Revision Knee System Surgical Protocol

2 Proven Gen-Flex Revision Knee System Surgeon Design Team The Proven Gen-Flex Revision Knee System Instrumentation and Surgical Protocol were developed in conjunction with: Bret B. Greenky, M.D. Associate Professor, Department of Orthopedic Surgery State University of New York Health Science Center at Syracuse Co-Director Orthopedic Implant Service St. Joseph s Hospital Health Center Syracuse, NY Norman A. Johanson, M.D. Chair of Orthopaedic Surgery Drexel University, College of Medicine Philadelphia, PA Paul Nourbash, M.D. Orthopaedic Surgeon Alexian Brothers Health System Hoffman Estates, IL 2

3 Contents Page Preoperative Planning 4-5 Tibial Preparation 6-15 Intramedullary (IM) Tibial Resection Technique 7-10 Extramedullary (EM) Tibial Resection Technique Revision Tibia - Size and Determine Offset Revision Trial Tibia Assembly Modular Tibia Option Sizing and Trial Assembly Preoperative Planning Femoral Preparation Revision Trial Femur Assembly Trial Reduction 34 Patellar Preparation 35 Implant Assembly and Implantation Indications for Use 42 Appendix A 43 Implant Reference Chart Product Specifications 3

4 Preoperative Planning Preoperative planning is essential to good outcome in the revision setting. Infection must be ruled out with clinical history, examination, erythrocyte sedimentation rate and C-reactive Protein level. Imaging studies such as AP, lateral, Merchant view radiographs, fluoroscopic guided images and stress views, and a CT scan can be helpful to determine the mechanism of implant failure, assess the extent of bony damage, and help the surgeon prepare for the reconstruction in the revision setting. 4

5 It is also helpful to obtain images of the patient taken prior to the initial joint replacement. These images are useful in determining the level of the joint line, and the relationship with bony landmarks. If these preoperative images are not available consider images of the opposite knee. The Proven Gen-Flex Revision Knee System may be used in difficult primary total knee replacements and in revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present (see Indications for Use). The extent of bone loss and competence of ligamentous structures are important considerations to the success of the operation. The surgeon is advised to assess the need for augmentation to address progressive bone loss and/or the need for a hinged prosthesis to address ligamentous deficiency prior to final implant selection. CAUTION: During the revision surgery, the surgeon must take into consideration the fact that each tibial tray is compatible with only a limited number of femoral components. The general rule-ofthumb is that for each femoral component size there is a tibial component the same size, one size larger, and one size smaller. See the Proven Gen-Flex Knee System Sizing Chart (Appendix A) 5

6 IMPORTANT NOTE: All Proven Gen-Flex resection slots are designed for use with a.050" (1.27mm) thick saw blade, 19mm or less in width. Either the tibia or the femur can be prepared first. Tibial preparation is presented here first. Tibial Preparation If necessary, remove the existing implant component. Compare the explant against the appropriate Tibial Templates to determine a starting size. CAUTION: The tibial tray size must be compatible with the tibial insert and matching femoral component size selected. Ensure compatibility of the tibial tray size with the tibial insert and femur size by referring to the Proven Gen-Flex Knee System Sizing Chart (see Appendix A). Intramedullary or extramedullary tibial resection instruments may be used with the Proven Gen-Flex Revision Knee System. CAUTION: The recommended posterior tibial slope is 0 to replicate the 0 posterior slope of the tibial stem relative to the tibial base. NOTE: Two tibial trays that accept stems are available to the surgeon. The Revision Tibial Tray allows the stem to be offset from the tray and for augments to be fixed to the tray prior to cementing of the implant. The Modular Tibial Tray does not allow for stem offset and if augments are required, an additional step is necessary to cement the augments to the tray. 6

7 Intramedullary (IM) Tibial Resection Technique Ream Tibial Canal If necessary, a 5/16" (8mm) IM Drill is used to initiate an opening in the proximal tibia. Begin an initial reaming process with the 10mm or appropriate size reamer to establish the anatomic axis of the proximal tibia. Hand reaming may be appropriate to avoid a thin tibial cortex that could result in a fracture. Reamers are available in 10-24mm diameters in 2mm increments. They are marked with two groups of lines (femoral single line and tibial double line) to align with the cut surface of the proximal tibia or distal femur. The group of lines correspond to the reaming depth for 40mm, 80mm, and 120mm length Trial Stems and Implant Stems. 120mm Tibia Double Line Mark 80mm Tibia Double Line Mark 40mm Tibia Double Line Mark Implant and Trial Stems are the same diameter as the reamer. Cementless Stem implants are available in 10-24mm diameters in 2mm increments with splines that provide a slight interference fit. When a Cementless Stem is used the canal should be reamed to the desired stem diameter. Cemented Stem implants are available in 10-16mm diameters in 2mm increments. When a Cemented Stem is used the canal should be over reamed. Typically surgeons over ream by 2mm for a cemented stem. With the desired reaming complete, the final reamer is removed from the tibial canal. 7

8 IM Tibial Resection Technique (cont) IM Alignment Guide Assembly A Required Instrument Items D E B A T-Handle B Revision Knee IM Tibial Stem Rod C Trial Stem (corresponding to final reamed length and diameter) F C D IM Tibial Alignment Guide E IM Alignment Guide Rod Body F Revision Tibial Cut Block (Left or Right) A non-captured Revision Tibial Cut Block is the standard offering. An optional captured Revision Tibial Cut Block for use with an optional stylus or navigation is available. Assemble Tibial Cut Block Assemble the appropriate left or right Revision Tibial Cut Block to the IM Tibial Alignment Guide using the dovetail connection. Slide the alignment guide into the mating cut block dovetail until the detent engages. 8

9 Assemble Alignment Guide Assemble the alignment guide and cut block assembly to the IM Alignment Guide Rod Body. Slide the rod body posts into the mating alignment guide holes. Assemble Trial Stem Assemble the corresponding length and diameter Trial Stem to the Stem Rod using the quick connection. Push the Trial Stem into the mating connector and give 1/4 turn to fully engage. Note: The Trial Stem may be undersized to aid in insertion and removal with the reamed canal. Assemble the Trial Stem and Stem Rod construct into the rod body, alignment guide and cut block construct. The T-Handle may be assembled to the top of the Stem Rod to insert and/or remove the IM Alignment Guide assembly. The Tibial IM Alignment Guide Plate may be attached to the Rod Body to aid in stabilizing the IM Alignment Guide assembly, if needed. 9

10 IM Tibial Resection Technique (cont) CAUTION: The recommended posterior tibial slope is 0 to replicate the 0 posterior slope of the tibial stem relative to the tibial base. Insert the entire IM Alignment Guide construct into the reamed tibial canal. Adjust IM Alignment Guide Adjust the IM Alignment Guide Assembly for a sufficient clean-up cut with the aid of a saw blade, resection locator, or stylus. Turn the locking lever to set the cut block.. Locking Lever Pin Cut Block Pin the cut block to the proximal tibia. A X-Pin hole is provided if needed. Resect Proximal Tibia A proximal tibial resection can be made with or without the Alignment Guide and Trial Stem in place. If the Alignment Guide is removed, the Trial Tibial Tray Handle can be assembled to the cut block and used with the External Alignment Rod as a double check. Top Surface Clean-Up Cut 5mm Augment Resection Slot 10mm Augment Resection Slot If necessary, begin the clean-up resection using the top surface of the non-captured cut block or the 0mm top slot of the captured cut block. Select Tibial Augments If augmentation is needed, the Revision Tibial Cut Block provides resection slots for 5 and 10mm half block augments that can be placed independently on the medial or lateral side of the tibia. The medial-lateral width of half block cuts should coincide with the mid-line of the tibial canal. 10 IMPORTANT NOTE: All Proven Gen-Flex resection slots are designed for use with a.050" (1.27mm) thick saw blade, 19mm or less in width.

11 Extramedullary (EM) Tibial Resection Technique EM Alignment Guide Assembly A B Required Instrument Items C A Revision Tibial Cut Block B Alignment Guide Rod C Alignment Guide Base D Ankle Clamp Assembly D Assemble the appropriate left or right Revision Tibial Cut Block to the Alignment Guide Rod. Assemble the Alignment Guide Rod into the Alignment Guide Base. Assemble the Ankle Clamp Assembly to the Alignment Guide Base. 11

12 EM Tibial Resection Technique (cont) CAUTION: The recommended posterior tibial slope is 0 to replicate the 0 posterior slope of the tibial stem relative to the tibial base. Position Ankle Clamp Assembly Position the Ankle Clamp Assembly against the lower leg just proximal to the malleoli and wrap around the leg. Top Surface Clean-Up Cut 5mm Augment Resection Slot 10mm Augment Resection Slot Alignment Guide Base Knob (Slope Adjustment) Ankle Clamp Knob (Varus / Valgus Adjustment) Set Alignment Guide Base Set the Alignment Guide Base and Ankle Clamp adjustment knobs to assure no posterior slope and neutral varus/valgus alignment of the proximal tibia resection. Adjust Alignment Guide Rod Adjust the Alignment Guide Rod for a sufficient clean-up cut with the aid of a saw blade, resection locator, or stylus. Turn the alignment guide locking knob to set the cut block. Pin Cut Block Pin the cut block to the proximal tibia. A X-Pin hole is provided if needed. Resect Proximal Tibia A proximal tibial resection can be made with or without the Alignment Guide in place. The Trial Tibial Tray Handle can be assembled to the cut block and used with the External Alignment Rod as a double check. If necessary, begin the clean-up resection using the top surface of the non-captured cut block or the 0mm top slot of the captured cut block. Select Tibial Augments If augmentation is needed, the Revision Tibial Cut Block provides resection slots for 5 and 10mm half block augments that can be placed independently on the medial or lateral side of the tibia. Alignment Guide Locking Knob 12 The medial-lateral width of half block cuts should coincide with the mid-line of the tibial canal. IMPORTANT NOTE: All Proven Gen-Flex resection slots are designed for use with a.050" (1.27mm) thick saw blade, 19mm or less in width.

13 Ream Tibial Canal If necessary, a 5/16" (8mm) IM Drill is used to initiate an opening in the proximal tibia. Begin an initial reaming process with the 10mm or appropriate size Reamer to establish the anatomic axis of the proximal tibia. Hand reaming may be appropriate to avoid a thin tibial cortex that could result in a fracture. Reamers are available in 10-24mm diameters in 2mm increments. They are marked with two groups of lines (femoral single line and tibial double line) to align with the cut surface of the proximal tibia or distal femur. The group of lines correspond to the reaming depth for 40mm, 80mm, and 120mm length Trial Stems and Implant Stems. 120mm Tibia Double Line Mark 80mm Tibia Double Line Mark 40mm Tibia Double Line Mark Implant and Trial Stems are the same diameter as the reamer. Cementless Stem implants are available in 10-24mm diameters in 2mm increments with splines that provide a slight interference fit. When a Cementless Stem is used the canal should be reamed to the desired stem diameter. Cemented Stem implants are available in 10-16mm diameters in 2mm increments. When a Cemented Stem is used the canal should be over reamed. Typically surgeons over ream by 2mm for a cemented stem. With the desired reaming complete, the final reamer is removed from the tibial canal. 13

14 Revision Tibia - Size and Determine Offset Size Tibia Select the Revision Tibial Template size that provides the optimal proximal tibial bone coverage. CAUTION: The tibial tray size must be compatible with the tibial insert and matching femoral component size selected. Ensure compatibility of the tibial tray size with the tibial insert and femur size by referring to the Proven Gen-Flex Knee System Sizing Chart (see Appendix A). If necessary, assemble the appropriate size and thickness Trial Tibial Half Block by snapping to the tibial template. The Trial Tibial Tray Handle can also be assembled to the mating dovetail of the tibial template to aid in placement. Determine Offset Assemble the corresponding length and diameter Trial Stem to the Tibial Position Dial using the quick connection. Push the Trial Stem into the mating connector and give 1/4 turn to fully engage. 0, 2, & 4mm Stem Offset Marks Note: The Trial Stem may be undersized to aid in insertion and removal with the reamed canal. Set Position Dial Set the position dial to the 0mm offset by loosening the wing nut and sliding to the 0 Mark. Retighten wing nut. Evaluate Tibial Coverage Place the tibial template construct onto the proximal tibia. Insert the position dial and stem assembly set at 0mm, through the tibial template central hole and into the prepared tibial canal. Evaluate proximal tibia coverage. Note: Two tibial trays that accept stems are available to the surgeon. The Revision Tibial Tray allows the stem to be offset from the tray and for augments to be fixed to the tray prior to cementing of the implant. The Modular Tibial Tray does not allow for stem offset and if augments are required, an additional step is necessary to cement the augments to the tray. 14

15 Tibial Position Dial Wing Nut If a 2 or 4mm stem offset is required, loosen the position dial wing nut and adjust by sliding to the required offset and retighten. Rotate the position dial and tibial template until optimal proximal tibial coverage is achieved. The position dial letter/number combination mark lining up with the tibial template anterior witness line mark is noted. IMPORTANT: To accurately reproduce the stem offset the following information is needed. - Offset (0,2,4 mm) - If the offset is 0 no additional information is needed If there is 2 or 4mm of offset then additional information is needed - Quadrant Letter (A, B, C, or D) - Quadrant Number (1-8) Tibial Position Dial Letter/Number Mark and Revision Tibial Template Anterior Mark This information determines which offset bushing is used. There are two types of bushings available AC and BD. If the position of the mark falls between the letter quadrants then either bushing can be used. Secure Tibial Template Use Headed Pins to secure the tibial template to the proximal tibia and remove the position dial and stem assembly. The Trial Tibial Tray Handle can be assembled to the tibial template and used with the External Alignment Rod as a double check. Drill and Punch for Keel Insert the Revision Tibial Boss Reamer Bushing into the tibial template. Ream using the Revision Tibial Boss Reamer until flush with the stop. Remove the reamer and bushing. Insert the Revision Tibial Keel Bushing into the tibial template. Slide the assembled Revision/Modular Tibial Keel Punch through the Revision Tibial Keel Bushing. Impact until the punch is fully seated. Remove the keel punch, bushing, and pinned tibial template. 15

16 Revision Trial Tibia Assembly Assemble Handle Assemble one of the two blue Silicone Square Drive Handles to the Revision/Modular Tibial Keel Wrench. Select and Insert Tibial Bushing Select the appropriate (0, 2AC, 2BD, 4AC or 4BD) Trial Tibial Offset Bushing as recorded during the Size Tibia and Determine Offset sequence. Insert the selected offset bushing dovetail into the anterior opening of the appropriate size Revision Trial Tibial Tray. Give offset bushing 1/4 turn. Tibial Keel Wrench Anterior Mark Place Keel Wrench Place the keel wrench over the tibial tray keel so that the anterior mark is oriented correctly. Assemble Bushing Assemble the Revision Knee Tibial Bushing Dial into the keel wrench and over the offset bushing until flush. Rotate the bushing dial until the letter/number combination recorded during the Determine Offset sequence is aligned with the anterior witness mark of the keel wrench: - Letter Quadrant (A, B, C, or D) - Number in Quadrant (1-8) 16

17 Tighten the offset bushing screw using the 2.5mm (SILVER) Hex Driver Shaft and the second blue Silicone Square Drive Handle. DO NOT OVERTIGHTEN. Remove the bushing dial and keel wrench. Assemble Trial Stem Assemble the appropriate length and diameter Trial Stem to the offset bushing using the quick connection. Push the Trial Stem into the mating connector and give 1/4 turn to fully engage. The system provides two of each length and diameter trial stem in case the same sized stems are needed for both the tibia and femur. If necessary, assemble the appropriate size and thickness Trial Tibial Half Block by snapping to the trial Tibial Tray. Test Fit and Save Trial Insert the assembled trial tibial tray construct into the prepared tibia and evaluate fit. To remove the trial tibial tray construct from the prepared tibia, assemble the Tibial Tray Removal Tool to the Slap Hammer, insert into the trial tibial tray extraction hole, give 1/2 turn to engage, and use the slap hammer to extract. NOTE: Keep the trial tibial component assembled until the end of the procedure. The trial component can be useful in assembly of the final implant. 17

18 Modular Tibia Option Sizing and Trial Assembly Size Tibia Select the Modular Tibial Template size that provides the optimal proximal tibial bone coverage. CAUTION: The tibial tray size must be compatible with the tibial insert and matching femoral component size selected. Ensure compatibility of the tibial tray size with the tibial insert and femur size by referring to the Proven Gen-Flex Knee System Sizing Chart (see Appendix A). If necessary, assemble the appropriate size and thickness Trial Tibial Half Block by snapping to the tibial template NOTE: The Modular Tibial Tray implant requires cemented fixation of half block augments. The Revision Tibial Tray must be used if mechanical fixation of half block augments is desired. The Trial Tibial Tray Handle can also be assembled to the mating dovetail of the tibial template to aid in placement. Secure Tibial Template Place the tibial template construct onto the proximal tibia. Use Headed Pins to secure the tibial template to the proximal tibia. Drill and Punch for Keel Insert the Cemented Keel Drill into the tibial template. Drill until the stop is flush with the tibial template. Remove the keel drill. Slide the Revision/Modular Tibial Keel Punch through the tibial template. Impact until the punch is fully seated. Remove the keel punch and pinned tibial template. 18

19 Modular Trial Tibial Assembly Assemble Trial Stem Assemble the corresponding length and diameter Trial Stem to the appropriate size Trial Modular Tibial Tray using the quick connection. Push the trial stem into the mating connector and give 1/4 turn to fully engage. Note: The Surgeon may wish to use a stem 2mm smaller than the diameter reamed for ease of insertion and removal during the trial process. Two of each length and diameter trial stem are provided if needed for trialing the tibia and femur. If necessary, assemble the appropriate size and thickness Trial Tibial Half Block by snapping to the trial tibial tray. Test Fit and Save Trial Insert trial tibial construct into the prepared tibia and evaluate fit. To remove the trial tibial tray construct from the prepared tibia, assemble the Tibial Tray Removal Tool to the Slap Hammer, insert into the trial tibial tray extraction hole, give 1/2 turn to engage, and use the slap hammer to extract. NOTE: Keep the trial tibial component assembled until the end of the procedure. The trial component may be useful in assembly of the final implant. 19

20 Preoperative Planning Preoperative planning is essential to good outcome in the revision setting. Infection must be ruled out with clinical history, examination, erythrocyte sedimentation rate and C-reactive Protein level. Imaging studies such as AP, lateral, Merchant view radiographs, fluoroscopic guided images and stress views, and a CT scan can be helpful to determine the mechanism of implant failure, assess the extent of bony damage, and help the surgeon prepare for the reconstruction in the revision setting. 20

21 It is also helpful to obtain images of the patient taken prior to the initial joint replacement. These images are useful in determining the level of the joint line, and the relationship with bony landmarks. If these preoperative images are not available consider images of the opposite knee. The Proven Gen-Flex Revision Knee System may be used in difficult primary total knee replacements and in revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present (see Indications for Use). The extent of bone loss and competence of ligamentous structures are important considerations to the success of the operation. The surgeon is advised to assess the need for augmentation to address progressive bone loss and/or the need for a hinged prosthesis to address ligamentous deficiency prior to final implant selection. CAUTION: During the revision surgery, the surgeon must take into consideration the fact that each tibial tray is compatible with only a limited number of femoral components. The general rule-ofthumb is that for each femoral component size there is a tibial component the same size, one size larger, and one size smaller. See the Proven Gen-Flex Knee System Sizing Chart (Appendix A) 21

22 Femoral Preparation Remove Implant and Size Take care to remove as little bone as possible when removing the femoral component. Compare the size of the implant removed to trial femoral components or the Femoral Sizing Guides, to help determine what sized femoral component to implant. Placing the trial component against the remaining femoral bone after the implant has been removed is useful in determining size and determining if femoral augments are needed. Two stems of each length and diameter are provided in case the stems for the femur and tibia are the same size. CAUTION: The femoral component size must match the size of the tibial insert. Ensure compatibility of the femoral component with the tibial insert and tibial tray size by referring to the Proven Gen-Flex Knee System Sizing Chart (see Appendix A). Two of each length and diameter Trial Stems are provided to facilitate assembly of subsequent steps and if needed for trialing. 22

23 Ream Femoral Canal If necessary, a 5/16" (8mm) IM Drill is used to initiate an opening in the distal femur. Begin an initial reaming process with the 10mm or appropriate size Reamer. Hand reaming may be appropriate to avoid a thin femoral cortex that could result in a fracture. 120mm Femur Single Line Mark 80mm Femur Single Line Mark 40mm Femur Single Line Mark Reamers are available in 10-24mm diameters in 2mm increments. They are marked with two groups of lines (femoral single line and tibial double line) to align with the cut surface of the proximal tibia or distal femur. The group of lines correspond to the reaming depth for 40mm, 80mm, and 120mm length Trial Stems and Implant Stems. Implant and Trial Stems are the same diameter as the reamer. Cementless Stem implants are available in 10-24mm diameters in 2mm increments with splines that provide a slight interference fit. When a Cementless Stem is used the canal should be reamed to the desired stem diameter. Cemented Stem implants are available in 10-16mm diameters in 2mm increments. When a Cemented Stem is used the canal should be over reamed. Typically surgeons over ream by 2mm for a cemented stem. With the desired reaming complete, the final reamer is removed from the femoral canal. Femoral Alignment is based off of the Trial Stem that is the same size as the reamer. 23

24 Femoral Preparation (cont) Distal Femoral Alignment Guide Assembly A Required Instrument Items B A Femoral Distal Cut Block B Femoral Distal Resection Guide C Femoral Alignment Block (5 or 7 ) D Distal Femoral Alignment Guide Knob C E Trial Stem (corresponding to final reamed length and diameter) D E Assemble Distal Resection Guide Assemble the Femoral Distal Resection Guide to the Femoral Distal Cut Block. Assure that the Femoral Distal Cut Block is against the Distal Femoral Resection Block stop for the standard non-captured 2mm clean-up cut. Distal Femoral Resection Guide Stop 24

25 Assemble Femoral Alignment Block Assemble the Femoral Distal Resection Guide and the Femoral Distal Cut Block assembly to the Femoral Alignment Block by inserting the two resection guide posts into the alignment block holes. There are two Femoral Alignment blocks available 5 or 7. Secure using one of the two provided Distal Femoral Alignment Guide Knobs. Assure that the appropriate joint side (Left or Right) marking is visible on the face of Femoral Alignment Block. (LEFT SHOWN). Left or Right Joint Side Marking Assemble Trial Stem Assemble the appropriate length and diameter Trial Stem to the Femoral Alignment Block using the quick connection. Push the Trial Stem into the mating connector and give 1/4 turn to fully engage. Note: The Trial Stem may be undersized to aid in insertion and removal with the reamed canal. 25

26 Femoral Preparation (cont) Insert the Distal Femoral Resection Guide assembly into the reamed femoral canal until the femoral alignment block is flush with the distal femur. The distal femoral resection depth may be checked with the aid of a saw blade or resection locator. Femoral Distal Resection Guide Slide Detent If additional proximal positioning of the distal cut block is needed, push the Femoral Distal Resection Guide slide detent to advance the cut block in 1mm increments. Pin Cut Block to Distal Femur Pin the cutting block to the femur using holes labeled 0. This allows for a 2mm adjustment of the block without moving the pins. Once the block is in the correct position then place a pin in the oblique holes ( X-pinholes) for additional stability. Remove Distal Resection Guide Remove the Femoral Distal Resection Guide and Femoral Alignment Block assembly using the Femoral Alignment Block Extractor assembled to Slap Hammer, if needed. 26

27 Top Surface Clean-Up Cut 5mm Augment Resection Slot 10mm Augment Resection Slot Resect Distal Femur If necessary, begin the clean-up resection using the top surface of the distal cut block. If augmentation is needed, the distal cut block provides resection slots for 5 and 10mm distal augments that can be placed independently on the medial or lateral side of the femur. Marks on the distal face of the distal cut block also provide medial/ lateral sizing of the femoral component. IMPORTANT NOTE: All Proven Gen-Flex resection slots are designed for use with a.050" (1.27mm) thick saw blade, 19mm or less in width. 27

28 Femoral Preparation (cont) 4 in 1 Cut Block Assembly Select the appropriate size 4 in 1 Cut Block. Select and Assemble Augments If Augments are needed after distal femoral resection, Femoral Cut Block Augments need to be attached to the 4 in1 Cut Block. Assemble the cut block augments to the proximal side of the 4 in 1 Cut Block by aligning the tab on the augment with the corresponding slot in the cut block. Secure using the 2.5mm (SILVER) Hex Driver Shaft and the blue Silicone Square Drive Handle. Two of each size and thickness Femoral Cut Block Augments are provided to facilitate assembly of subsequent steps if needed. Assemble Trial Stem Assemble the appropriate length and diameter Trial Stem to the 4 in 1 Cut Block using the quick connection. Push the Trial Stem into the mating connector and give 1/4 turn to fully engage. 28

29 Anterior Reference Guide Hex Knob Driver Insert Cut Block Insert the 4 in 1 Cut Block assembly into the reamed femoral canal. Ensure the cut block is flush with the distal femur. Establish rotation of the cut block relative to the epicondylar axis of the distal femur. Set AP Position of 4 in1 Cut Block Insert the 2.5mm Hex Knob Driver into the top of the 4 in 1 Cut Block. The 2.5mm (SILVER) Hex Driver Shaft and Silicone Handle assembly may also be used. Insert the Anterior Reference Guide through the anterior resection slot. Assure that the appropriate L or R marking is visible. Trial and Implant Valgus Bushing Placement Turn the 2.5mm hex knob driver or driver shaft until the reference guide touches the anterior femur. Note the location of the valgus bushing pointer (anterior or posterior of the 0 marking). IMPORTANT: Record this calibration mark position. The number on the front of the 4 in 1 Cut Block corresponds to the position of the bushing on the Femoral Trial. Make sure you note if it is anterior or posterior to the zero mark. Stabilize Cut Block Stabilize the block using 1/8" (3.2mm) diameter pins on the medial and lateral sides of the block. The fixation holes can be predrilled with a 1/8" diameter drill bit. Handles are also available to provide additional stability. Valgus Bushing Placement Pointer Resect AP and Chamfer Cuts Femoral resections are performed through the anterior, anterior chamfer, posterior chamfer, and posterior resection slots. Resect for posterior augments, if necessary. 10mm Augment Resection Slot 5mm Augment Resection Slot 0mm Resection Slot IMPORTANT NOTE: All Proven Gen-Flex resection slots are designed for use with a.050" (1.27mm) thick saw blade, 19mm or less in width. 29

30 A Femoral Preparation (cont) Box Cut Guide Assembly B D Required Instrument Items A Revision Femoral Box Cut Guide C B Revision Femoral Stem Inserter C Femoral Cut Block Valgus Bushing (5 or 7 ) D Trial Stem (corresponding to final reamed length and diameter) E E T-Handle NOTE: The box cut guide should always be used when a femoral stem extension is indicated. This will help ensure accurate placement of the final femoral implant. Each femoral size needs a different box cut. Take care to select the appropriate size Revision Femoral Box Cut Guide. Assemble Augments If Augments were needed after distal femoral resection they will need to be affixed to the Femoral Block Cut Guide. Assemble the cut block augments to the proximal side of the Box Cut Guide by aligning the tab on the augment with the corresponding slot in the cut block. Secure using the 2.5mm (SILVER) Hex Driver Shaft and the blue Silicone Square Drive Handle Assemble Valgus Bushing Assemble the appropriate 5 or 7 Femoral Cut Box Valgus Bushing over the Revision Femoral Stem Inserter as shown. 30

31 Assemble T-Handle and Trial Stem Assemble the T-Handle to the stem inserter. Assemble the appropriate length and diameter trial stem to the stem inserter using the quick connection. Push the Trial Stem into the mating connector and give 1/4 turn to fully engage. Place the box cut guide onto the femur. Anterior Left or Anterior Right Marking Insert the stem inserter assembly into the reamed femoral canal and over the box cut guide. Ensure the correct markings on the valgus bushing are facing Anterior for Right or Anterior for Left. Stabilize Cut Block Stabilize the box cut guide with fixation pins into the available bone stock. Remove Stem Inserter Remove the stem inserter assembly leaving only the box cut guide in place. Saw Guide Resect Box Cut Using a narrow oscillating or reciprocating saw blade, resect the medial and lateral sides of the femoral box. Complete the bottom of the notch resection using a saw blade or an osteotome. The distal cut of the femur should be parallel to the distal surface of the saw guide. 31

32 Revision Trial Femur Assembly CAUTION: The femoral component size must match the size of the tibial insert. Ensure compatibility of the femoral component with the tibial insert and tibial tray size by referring to the Proven Gen-Flex Knee System Sizing Chart (see Appendix A). Assemble Trial Valgus Bushing Place the same degree Trial Valgus Bushing into the posterior opening of the appropriate Revision Knee Trial Femur. The appropriate joint side left (L) or right (R) marking on the valgus bushing should be visible from the posterior side of the femur (left L SHOWN). Assemble Trial Augment If any distal or posterior augment resections were made, select the required size and thickness medial and/or lateral Trial Femoral Posterior and/or Distal Augments Attach the augments to the femur from the articulating side using the 2.5mm (SILVER) Hex Driver Shaft and the blue Silicone Square Drive Handle The augments may be assembled in any order or combination. 32

33 Assemble Trial Stem Assemble the appropriate length and diameter Trial Stem to the valgus bushing using the quick connection. Push the Trial Stem into the mating connector and give 1/4 turn to fully engage. Two of each length and diameter Trial Stems are provided in case the same sized Trial Stem is needed in both the tibia and femur. Set Valgus Bushing Position Tighten the Trial Valgus Bushing from the articulating side of the Trial Femur to the required A/P position using the 3.5mm (GOLD) Hex Driver Shaft and one of the blue Silicone Square Drive Handles as determined by one of the two following methods: Method 1 - Trial Femur Assembly With the appropriate valgus bushing and stem assembled but not tightened, insert the Revision Knee Femoral Trial into the femoral canal. Slide the trial femur until the anterior flange rests on the anterior cortex. Tighten the valgus bushing, remove the trial construct and note the bushing calibration mark position on the trial femur. IMPORTANT: Record this calibration mark position. This determines the position of Implant Valgus Bushing on the Revision Femur. Compare this number with the number on the 4 in1 Cut Block. Valgus Bushing Placement Pointer Method 2-4 in 1 Cut Block Pointer Position the Valgus Bushing until the witness mark on the side of the bushing corresponds to the calibration mark on the Trial Femur as recorded using the Revision 4 in 1 Cut Block during femoral preparation. Assemble the appropriate length and diameter Trial Stem to the valgus bushing using the quick connection. Push the Trial Stem into the mating connector and give 1/4 turn to fully engage. If the Trial Femur does not seat properly, loosen the Trial Valgus Bushing and use Method 1. 33

34 Trial Reduction CAUTION: Ensure that the correct size femoral component, tibial base, and tibial insert are chosen based on component interchangeability by referring to the Proven Gen-Flex Knee System Sizing Chart (see Appendix A). If needed, a Revision Trial Tibial Insert Pin is available to secure the Revision Trial Tibial Insert to the Trial Tibial Tray. Two of each Revision Trial Tibial Insert Pins are provided so that two inserts can be more easily compared during trialing. Trial Fit and Save Trials If previously removed, replace the appropriate trial tibial and femoral constructs to the prepared bones using the appropriate inserters and/ or impactors. Assess joint stability, alignment, range of motion and patellar tracking. NOTE: Keep the trial components assembled until the end of the case to aid in assembly of the final implant construct. 34

35 Patellar Preparation In most revision cases, the patella is revised. If it is worn, loose, or does not track well it should be revised at the cement interface preserving as much bone as possible, resect the patella. Place the drill guide on the patella and note the appropriate size. Drill through the guide, 3 holes in the triangular pattern for the 3-peg patella or 1 center hole for the single peg patella using the appropriate patella stop drill. NOTE: All diameter patellae are interchangeable with all femur sizes in this system. An overall assessment of joint stability and range of motion is completed prior to removal of the trial components. Make any necessary soft tissue releases at this time. Remove the trial components and begin to construct the final implants. 35

36 Implant Assembly and Implantation Revision Femur CAUTION: The femoral component size must match the size of the tibial insert. Ensure compatibility of the femoral component with the tibial insert and tibial tray size by referring to the Proven Gen-Flex Knee System Sizing Chart (see Appendix A). Femoral Valgus Bushing Assembly Valgus Bushing Calibration Mark Insert Valgus Bushing Slide the appropriate angle Revision Femur Valgus Bushing into the posterior opening of the femur. The appropriate joint side left (L) or right (R) marking on the valgus bushing should be visible from the posterior side of the femur (left L SHOWN). Set Valgus Bushing Position Position valgus bushing so that the witness mark on bushing corresponds to the calibration mark on the femur as recorded from the Trial Femur Positioning or 4 in1 Cut Block Pointer. Initially tighten the valgus bushing to the femur at the required calibration mark using the 3.5mm (Gold) Hex Driver Shaft and the blue Silicone Square Drive Handle Final Tightening of Valgus Bushing To set the final position of the valgus bushing, use the T-Handle Torque Wrench 1/4 drive and the 3.5mm Hex Adapter. Insert the 3.5mm hex end into the valgus bushing set screw. Turn the torque wrench clock-wise until a single audible click is heard. Femoral Stem Assembly Screw the appropriate stem into the valgus bushing. Lock Stem into place, using the T-Handle Torque Wrench 1/4 drive and Stem Torque Adapter by sliding the torque adapter over the stem tri-slots. Turn the torque wrench clock-wise until a single audible click is heard. 36

37 Femoral Augment Assembly Select Appropriate Augments Select the appropriate thickness Distal and/or Posterior Femoral Augments and size corresponding with the femur. The augments are packaged with attachment screws and may be assembled to the femur in any order or combination. NOTE: The posterior augment screws go in at an angle to avoid interference with the anterior flange of the femur. Tighten Augment Screws Initially tighten the augment and attachment screw to the femur from the non-articulating side using the 3.5mm (Gold) Hex Driver Shaft and the blue Silicone Square Drive Handle Lock Augment Screws Lock Augments into place, using the T-Handle Torque Wrench 1/4 drive and the 3.5mm Hex Adapter by inserting the 3.5mm hex end into the augment screw and turning the torque wrench clock-wise until a single audible click is heard. NOTE: As a final check compare the implant to the trial component previously constructed. Also place the implant on the femur to make sure it seats properly before mixing cement. Impact Final Femoral Implant Construct Using the Femur Inserter/Extractor, impact the final Femoral Implant construct to the prepared bone. 37

38 Implant Assembly and Implantation (cont) Revision Tibia CAUTION: The tibial tray size must be compatible with the tibial insert size and matching femoral component size selected. Ensure compatibility by referring to the Proven Gen-Flex Knee System Sizing Chart ( see Appendix A). Tibial Offset Bushing Assembly Assemble one of the two blue Silicone Square Drive Handles to the Revision/Modular Tibial Keel Wrench. Tibial Keel Wrench Anterior Mark Select Tibial Offset Bushing Select the appropriate (0, 2AC, 2BD, 4AC or 4BD) implant Tibial Offset Bushing as recorded during the Size Tibia and Determine Offset sequence or Revision Trial Tibia Assembly. Insert Tibial Bushing Insert the offset bushing dovetail into the anterior opening of the implant Revision Tibial Tray keel boss. Give offset bushing 1/4 turn. Place Keel Wrench Place the keel wrench over the tibial tray keel so that the anterior mark is oriented correctly. Assemble Tibial Bushing Dial Assemble the Revision Knee Tibial Bushing Dial into the keel wrench over the offset bushing until flush. Rotate to Correct Position Rotate the bushing dial until the letter/number combination recorded during the Size Tibia and Determine Offset sequence or Revision Trial Tibia Assembly is aligned with the anterior witness mark of the keel wrench: - Letter Quadrant (A, B, C, or D) - Number in Quadrant (1-8) 38

39 Initially tighten the offset bushing screw using the 3.5mm (GOLD) hex driver with the second Modular Silicone Handle Remove the bushing dial. Lock Tibial Bushing To set final position of Tibial Bushing and lock into place, use the T- Handle Torque Wrench 1/4 drive and the 3.5mm Hex Adapter by inserting the 3.5mm hex end into the bushing set screw and turning the torque wrench clock-wise until a single audible click is heard. Tibial Stem Assembly Screw the appropriate Stem into the Tibial Bushing. Lock the stem into place using the T-Handle Torque Wrench 1/4 drive and Stem Torque Adapter by sliding the torque adapter over the stem tri-slots and turning the torque wrench clock-wise until a single audible click is heard. Tibial 1/2 Block Augment Assembly If required, assemble one the two Modular Silicone Handles to the 2.5mm (SILVER) Hex Driver. Screw in Augments Screw the appropriate corresponding size and thickness implant Revision Tibial 1/2 Block Augment(s) onto the Revision Tibial Implant construct by hand using the 2.5mm (SILVER) hex driver assembly. NOTE: As a final check compare the implant to the trial component previously constructed. Also place the implant on the tibia to make sure it seats properly before mixing cement. Impact Tibial Tray Construct Using the Tibial Tray Impactor, impact the Revision Tibial Tray construct to the prepared tibia. 39

40 Implant Assembly and Implantation (cont) Modular Tibial Tray (used when no offset is needed) CAUTION: The tibial tray size must be compatible with the tibial insert size and matching femoral component size selected. Ensure compatibility by referring to the Proven Gen-Flex Knee System Sizing Chart ( see Appendix A). Tibial Stem Assembly Remove End Cap Remove the factory assembled end cap from the Modular Tibia Tray implant and discard. Screw the appropriate Stem Implant into the tibial tray. Lock Stem into Tray Lock the stem into place using the T-Handle Torque Wrench 1/4 drive and Stem Torque Adapter by sliding the torque adapter over the stem tri-slots and turning the torque wrench clock-wise until a single audible click is heard. Tibial 1/2 Block Augment Assembly Cement Augments If required, cement the appropriate corresponding size and thickness implant Tibial 1/2 Block Augment(s) onto the appropriate medial or lateral side of the Modular Tibial Implant construct by using one of the two provided Patella Cement Clamps. Assure that the blue silicone pad of the clamp engages the proximal tibial tray geometry and that the spiked pad of the clamp engages the distal Tibial 1/2 Block geometry. NOTE: You may wish to consider cementing the patella component at the same time as the tibial augment to save step later. NOTE: As a final check compare the implant to the trial component previously constructed. Also place the implant on the tibia to make sure it seats properly before mixing cement. Impact Tibial Tray Construct Using the Tibial Tray Impactor, impact the Modular Tibial Tray construct to the prepared tibia. 40

41 Revision Tibial Insert CAUTION: The tibial insert size must be compatible with the tibial tray size and matching femoral component size selected. Ensure compatibility by referring to the Proven Gen-Flex Knee System Sizing Chart ( see Appendix A). Two size specific (1-2-3 or 4-5) Tibial Insert Impactors are available to assemble the Revision Knee Tibial Insert into either the Revision or Modular Tibial Tray. Assemble Tibial Insert Assemble the tibial insert to the tibial tray by aligning the factory assembled insert support post with the hole in the Revision or Modular tibial tray. NOTE: The constrained REVISION Tibial Insert is NOT compatible with the PRIMARY Tibial Tray implant. The appropriate size insert impactor is placed over the tibial insert central post and onto the articulating surface. Assure that the insert impactor face marked Anterior is positioned correctly. Impact Tibial Insert Using a mallet, impact the tibial Insert until the implant snaps into the tibial tray. Final Assessment A final assessment of joint motion, stability, alignment, and patellofemoral tracking is performed and routine wound closure is completed. 41

42 GENERAL PRODUCT INFORMATION Through the advancement of partial and total knee joint replacement, the surgeon has been provided with a means of restoring mobility, correcting deformity, and reducing pain for many patients. While the prostheses used are largely successful in attaining these goals, it must be recognized that they are manufactured from metal and plastic materials and that any joint replacement, therefore, cannot be expected to withstand activity levels and loads as would normal healthy bone. In addition, the system will not be as strong, reliable, or durable as a natural human joint. INDICATIONS FOR USE Stelkast Company knee implant components are indicated for single use only in skeletally mature individuals undergoing reconstruction of severely disabled and/ or very painful joints. Stelkast Proven Knee System components are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/ or post-traumatic degenerative problems, revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present, and for cemented use only. Stelkast Unicondylar Knee System components are indicated for unicompartmental knee replacement due to moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis, revision of previous unsuccessful unicompartmental knee replacement or other procedure, as an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, and for cemented use only. CONTRAINDICATIONS Stelkast Company knee implant components are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, muscle laxity or inadequate soft tissue for proper function and healing, any pathological conditions that would interfere with the performance of the system and in patients with either mental or neuromuscular disorders that do not allow control of the affected joint, and in patients whose weight, age or activity level might cause extreme loads and early failure of the system. WARNINGS AND PRECAUTIONS Familiarity with and attention to appropriate surgical technique for knee joint arthroplasty and the Stelkast implant system is essential for success of the procedure. Improper position of the components could result in dislocation. Only surgeons who have reviewed the literature regarding knee surgery and have had training in the technique should utilize the device. Patient selection is based on age, bone stock and size. The surgeon or his designee should instruct patients in the limitations of the prosthesis, and these patients should be taught to govern their activities accordingly. Patient lifestyles must be evaluated by the physician, and patient properly advised of any required modifications. Knee implant components must not be reused. The surgeon must not allow damage to polished bearing surfaces because this may accelerate wear of the components. Any alteration or damage to a component may reduce fatigue strength and could result in failure under load. Any prostheses so damaged must not be used. Components of Stelkast Company knee implants should not be used with those of another manufacturer since articular and dimensional compatibility cannot be assured. ADVERSE EVENTS As with all knee joint implant systems, potential adverse effects include infection, loosening of the components, breakage, bending or disassembly of the components, or change in position of the components. There have been reports of sensitivity reactions to the implant components. Other potential adverse effects of knee implant joint surgery include neurovascular damage, dislocation, thromboembolic disease, component failure and wear debris and other less common adverse effects. On rare occasions, amputations have been necessary. STERILITY AND HANDLING Each Stelkast Company knee implant component is supplied sterile in double sealed containers maintaining double sterile barriers. If the seals or containers are breached, then the component should not be used. The components are not represented to be "pyrogen-free."metal parts as well as polyethylene (UHMWPe) parts and/or components containing polyethylene are supplied exposed to a minimum of 2.5 Mrad of gamma irradiation or Ethylene Oxide sterilization and must be kept unopened in the double protective packaging until implantation. The sterilization method used is listed on the respective component label. The sterile container is to be checked for possible damage. Do not use any component if the packages have been breached. Resterilization by any method is ruled out. Care should be utilized in the handling of the components to minimize contamination of the component surfaces. Do not allow porous surfaces to come in contact with cloth or other fiber releasing materials. In using cement for fixation, the surgeon should use care to ensure complete cement support on all parts of the prosthesis embedded in bone cement. UTILIZATION AND IMPLANTATION Selection of Stelkast Company knee implant components depends on the judgment of the surgeon with regard to the relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the technique of implantation of the prostheses by: (1) appropriate reading of the literature, and (2) training in the operative skills and techniques required for knee joint arthroplasty surgery. MATERIALS USED The materials used are listed on the respective product label. INFORMATION For any further information, please contact the supplier. Please be sure to refer to the Catalog Number designated with REF CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. 42

43 Appendix A Proven Gen-Flex Knee System Sizing Chart Femur Insert Tibial Implant Black 1 Black 1 1T1F 2T1F Blue 2 Blue 2 1T2F 2T2F 3T2F Brown 3 Brown 3 2T3F 3T3F 4T3F Green 4 Green 4 3T4F 4T4F 5T4F Purple 5 Purple 5 4T5F 5T5F 43

44 Implant Reference Chart Proven Gen-Flex Revision Knee System Femoral Stem Valgus Bushing Posterior Augments Distal Augments Femoral Component Press Fit 80mm Black 10MM X 80MM 12MM X 80MM 1-5MM 1-5MM 1 14MM X 80MM 16MM X 80MM 1-10MM 1-10MM LEFT RIGHT 18MM X 80MM 20MM X 80MM Press Fit 120mm 22MM X 80MM 24MM X 80MM 2-5MM 2-5MM Blue 2 10MM X 120MM 12MM X 120MM MM 2-10MM LEFT RIGHT 14MM X 120MM 16MM X 120MM 18MM X 120MM 20MM X 120MM 22MM X 120MM 3 Brown 3 24MM X 120MM 3-5MM 3-5MM Cemented 40mm MM 3-10MM LEFT RIGHT 10MM X 40MM 12MM X 40MM Cemented 80mm 14MM X 40MM 16MM X 40MM 7 4-5MM 4-5MM Green 4 10MM X 80MM 12MM X 80MM 14MM X 80MM 4-10MM 4-10MM LEFT RIGHT 16MM X 80MM Cemented 120mm 10MM X 120MM 12MM X 120MM 5-5MM 5-5MM Purple 5 14MM X 120MM 16MM X 120MM 5-10MM 5-10MM LEFT RIGHT 44

45 Tibial Insert Tibial Tray Tibial Half Block Tibial Offset Bushing Tibial Stem Black 1 1T1F 1 10MM 1 12MM 1 14MM 1 17MM 1 20MM 2T1F 1 23MM 1 26MM 1 30MM Press Fit 80mm 1-5MM 10MM X 80MM 1-10MM 12MM X 80MM 14MM X 80MM 16MM X 80MM 2-5MM 18MM X 80MM 2-10MM 20MM X 80MM Blue 22MM X 80MM 2 1T2F 1-5MM 24MM X 80MM 2 10MM 1-10MM 2 12MM 2 14MM 2 17MM 2T2F 2-5MM 2-10MM 0 ACBD Press Fit 120mm 10MM X 120MM 2 20MM 12MM X 120MM 2 23MM 2 26MM 2 30MM 3T2F 3-5MM 3-10MM 2 AC 14MM X 120MM 16MM X 120MM Brown 3 2T3F 2-5MM 18MM X 120MM 20MM X 120MM 3 10MM 3 12MM 3 14MM 3 17MM 3T3F 2-10MM 3-5MM 3-10MM 2 BD 22MM X 120MM 24MM X 120MM 3 20MM 3 23MM 3 26MM 3 30MM Green 4 4T3F 3T4F 4-5MM 4-10MM 3-5MM 4 AC Cemented 40mm 10MM X 40MM 12MM X 40MM 14MM X 40MM 4 10MM 3-10MM 16MM X 40MM 4 12MM 4 14MM 4 17MM 4 20MM 4T4F 4-5MM 4-10MM 4 BD Cemented 80mm 10MM X 80MM 4 23MM 4 26MM 4 30MM 5T4F 5-5MM 5-10MM 12MM X 80MM 14MM X 80MM Purple 16MM X 80MM MM 5 12MM 5 14MM 5 17MM 4T5F 4-5MM 4-10MM Cemented 120mm 10MM X 120MM 12MM X 120MM 5 20MM 5 23MM 5 26MM 5T5F 5-5MM 5-10MM 14MM X 120MM 16MM X 120MM 5 30MM 45