U2 MBC. Knee Surgical Protocol

Transcription

1 U2 MBC Knee Surgical Protocol

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3 Table of Contents Products Review... Pre-Operative Planning... Surgical Incision... A. Femoral Preparation A.1. Pilot Hole... A.2. Femoral Valgus Angle Confirmation... A.3. Distal Femur Cutting... A.4. Femoral Component Sizing... A.5. A-P Chamfer Cutting... B. Tibial Preparation B.1. Tibial Intramedullary Alignment Method B.1.1.Pilot Hole... B.1.2. Tibial Cutting Jig Positioning and Tibial Resection... B.2. Tibial Extramedullary Alignment Method... B.3. Extension and Flexion Gap Confirmation... C. Trial Reduction for MBC Knee C.1. Femoral Trial Insertion... C.2. Tibial Baseplate Sizing... C.3. Creating Stem Space for Tibial Baseplate... C.4. Trial Reduction... D. Patellar Preparation D.1. Inset Patellar Component Preparation... D.1.1. Inset Patellar Reaming Depth and Pilot Hole... D.1.2. Drill Hole Completion and Trial Installation... D.2. Onset Patellar Component Preparation... E. Implant Fixation E.1. Final Trial Reduction... E.2. Implant Fixation... Order Information... Instrument Catalog... Safety Statement

4 Products Review U2 MBC Knee is designed with ultra-congruent concept which provides greater contact area and leads to less stress loading. The femoral component of U2 MBC is using criciate-retained (CR) type that intends to minimize bone cutting. The central stopper of the MBC insert enhances M/L stability while allowing 4.5 degrees hyperextension. U2 MBC knee adopted the basic cutting concept of U2 Knee System that is based on Anterior Reference System. The flexion and extension gaps of the distal femur can be prepared by choosing 0 or 3 external rotation to maintain the parallelism of femur in flexion and extension. Resection references for the tibia can be chosen regarding the use of Intramedullary Alignment or Extramedullary Alignment. Moreover, the instruments used for the preparation of the patella are designed to accurately restore the patellar thickness. An intraoperative choice can be made between the uses of Inset or onset patellar component. U2 MBC Knee Femoral Component, CR Tibial Insert, MBC Tibial Baseplate, MB 1

5 Pre-Operative Planning A thorough physical examination of the knee should be performed in a standard manner to evaluate the patient's overall knee function. Functional stability, muscle tone, ligamentous/capsular laxity and/or contractures, and potential bone loss are all considered. Both A-P and Lateral standing radiographs, with a known magnification, should be obtained and evaluated. Radiographs of the non-operative limb may also be taken to provide an additional reference. Additionally, the surgeon may elect to obtain A-P whole leg radiographs for both limbs to determine the current hip/knee/ankle mechanical axis and to allow for additional preoperative planning of the intended corrective osteotomies and resultant alignment/implant positioning. If intra-medullary alignment instrumentation is intended to be used, the shape and diameter of femoral and tibial canals should be evaluated to help assure the successful use and passage of intramedullary alignment devices into the bone canals. The intended implant size must also be evaluated on both A-P and lateral radiographs, by using the U2 Radiographic overlay templates. The magnification percentage of the templates used should approximate the known magnification of the radiographs. 2

6 Surgical Incision The surgeon may select to use any standard exposure method to perform the skin and capsular incision. If the medial parapatellar approach is selected, a straight midline skin incision, extending above and below the patella is applied to begin the exposure. The capsular exposure is then approached by utilizing a longitudinal medial parapatellar incision, typically extending upward to a level of one third of the rectus femoris or vastus medialis and downward to the medial side of the origin of patellar tendon on the tibial tuberosity. Once the exposure is completed, the patella is everted in a standard fashion, and the knee joint is inspected under vision. Careful assessment and removal of the ostoephytes should be undertaken. at this time ROM, patellar tracking, and soft tissue stability/instability should be evaluated again. It may be the preference of the surgeon to conduct a preliminary soft tissue release of the fixed contracted structures. Once completed, the knee is flexed to 90 degrees to perform the initial femoral pilot hole for the intramedullary alignment. 3

7 12F., No. 80, Sec. 1, Chenggong Rd., Yonghe Dist., New Taipei City 23452, Taiwan Tel: Fax:

8 1 Starter RB 2 8mm Twist Drill Alignment Rod Femoral IM Rod ,(400 mm) A. Femoral Preparation A.1. Pilot Hole With the ACL removed, the typical femoral entry hole location is thought to be slightly medial to the center of the intercondylar notch, and approximately 5 to 7 mm anterior to the anterior insertion of the PCL into the femur. Important note: As both varus and valgus deformities are commonly encountered in the total knee patient, careful evaluation of the possible A-P and M-L curvature of the femoral shaft should be undertaken to consider shifting the initial entry hole to a more appropriate location for each specific patient. A Starter 1 is used to mark the hole location, followed by the 8mm Twist Drill 2 to create an opening in the femoral canal. The drill is typically inserted to a depth of approximately 100mm within the femoral canal. After removal of the drill, intramedullary fluid of the femur may be reduced by inserting the small diameter Alignment Rod 3 into the femoral shaft several times. This will also identify the femoral canal. Once the canal is identified, the Femoral IM Rod 4 and T-Handle 5 is manually inserted into the femoral canal until the isthmus is engaged. Care should be taken when encountering the isthmus and make sure the rod can be completely pass through. Please note: If the canal isthmus diameter is thought to be too narrow for standard passage of the rod, advancement is discontinued, and an intraoperative radiograph may be employed to access the appropriate location of the rod. 5 T-Handle

9 A. Femoral Preparation A.2. Femoral Valgus Angle Confirmation Take the T-Handle 5 off. Adjust the valgus angle (range: 0-11 ) on the Femoral IM Alignment Guide 6 to the pre-operative estimated angle. Slip the Femoral IM Alignment Guide 6 through the Femoral IM Rod 4. Fix the Femoral IM Alignment Guide 6 with Spikes 8 to ensure the Guide is firmly contacted to the distal femur. The Alignment Rod 3 can be also attached to the Extramedullary Alignment Tower 7, following to the Femoral IM Alignment Guide 6 and directed towards to the center of the femoral head to confirm if the intended valgus angle is correct. 6 Femoral IM Alignment Guide RA 7 Extramedullary Alignment tower Spike

10 A. Femoral Preparation A.3. Distal Femur Cutting 9 Distal Femoral Alignment Guide RA 10 Distal Femoral Cutting Guide RC Attach the Distal Femoral Cutting Guide 10 to the Distal Femoral Alignment Guide 9. To secure the cutting guide, two 3.2 mm Twist Drills 11 are drilled into the "0" hole site on the distal femoral cutting guide. Prior to cutting the distal femur, additional fixation may be achieved by utilizing the Quick Pin Driver 12 to place additional pins in the medial and lateral pin holes. Once the instrument is secured, the resection is performed through the most distal slot in the instrument by using is a standard.050" (1.27 mm) thick saw blade. NOTE : The +3 mm slot option may also be selected for use if the surgeon wishes to resect an extra 3 mm thick distal bone. NOTE : +2 mm / +4 mm guide hole provides options to allow additional resection if desired at a later point in the procedure mm Twist Drill Quick Pin Driver RA 7

11 A. Femoral Preparation A.4. Femoral Component Sizing Extract the 3.2 mm Twist Drills 11 and Spikes 8 with a Pin Extractor 13 and remove the Distal Femoral Cutting Guide 10 after resection. Place a Femoral Sizer 14 flush against the resected distal femur, with the two feet rested flat against the posterior femoral condyles and ensure its stylus touching the lowest point of the anterior femoral cortex. The estimated size is indicated on the front and tight the screw of the Femoral Sizer 14. To estabilish a 3 external rotation, create the fixation pin holes with 3.2 mm Twist Drills 11 through the holes that correspond to the affected knee (left or right) on the front of the Femoral Sizer 14. The neutral position can simply be created by drilling the fixation pin holes through the drill holes labelled 0 on the front of the Femoral Sizer Pin Extractor Femoral Sizer Anterior Ref RE NOTE : The U2 Knee primary system is an anterior reference system. If the indicated size on the face of the guide is between two sizes, it is generally preferred to choose the smaller one. The additional bone resection will be removed from the posterior condyles. 3º External rotation Left/Right No rotation 8

12 15 Femoral A/P Chamfer Cutting Guide RC RC RC RC RC RC A. Femoral Preparation A.5. A-P Chamfer Cutting Fix the chosen Femoral A/P Chamfer Cutting Guide 15 in the predrilled fixation pin holes (Note: it must be placed flush against the resected distal femur). Use Spike 8 or Femoral A/P Chamfer Guide Handle 16 to enhance the stability during resection and check resection thickness with the Lower Point Gauge 17. Then, complete the four resection procedure with a 1.27 mm saw blade. At this point, the femoral preparation for posterior cruciate retaining femoral component is completed. 16 Femoral A/P Chamfer Guide Handle Lower Point Gauge, 1.3 mm

13 12F, No. 80, Sec. 1, Chenggong Road, Yonghe City, Taipei 234, Taiwan Tel: Fax:

14 B. Tibial Preparation 18 Tibial IM Rod There are two options for preparing tibial platforms. One is the intramedullary alignment method, and the other is the extramedullary alignment. B.1. Tibial Intramedullary Alignment Method B.1.1. Pilot Hole Flex the knee joint to the maximum angle and expose the whole tibial plateau by moving it anteriorly. Use the Starter 1 to create a pilot hole which is located at approximately 10 mm posterior to the origin of anterior cruciate ligament. Then, use an 8 mm Twist Drill 2 to create canal with a depth of approximately 100 mm into the tibial. After taking out the drill, it is recommended to apply an Alignment Rod 3 into the marrow cavity several times to reduce the risk of fat embolism. Connect the T-Handle 5 to the Tibial IM Rod 18 and insert the assembly manually into tibial canal through the narrowest point inside. Then, remove the T-Handle 5. If it is difficult to insert or align the Tibial IM Rod 18, enlarge the pilot hole with the 8 mm Twist Drill 2 again. 11

15 B. Tibial Preparation B.1.2. Tibial Cutting Jig Positioning and Tibial Resection Position the Tibial Cutting Jig 21 onto the Tibial IM Alignment Guide 19. With the thumb screw held loosely, the Tibial Stylus 20 may be used to establish the appropriate height position of the Tibial Cutting Jig 21. NOTE : The Tibial Stylus 20 allows two options to position the Cutting Guide: 2 mm or 9 mm cutting levels. When the Tibial Stylus 20 tip marked 2 mm is positioned on the low point of the tibial plateau, the bone resection will occur 2 mm below the contact point of the stylus tip. If the 9 mm stylus tip is positioned on the high point of the tibial plateau, it will position the Tibial Cutting Jig 21 9 mm below the contact point of the stylus tip. 19 Tibial IM Alignment Guide RA 20 Tibial Stylus RA With the Tibial Cutting Jig 21 properly positioned, two 3.2 mm Twist Drills 11 are placed into the 0 hole locations. Additional Drills 11 may be used in the peripheral holes provided. With the Tibial Cutting Jig 21 secured, the T-Handle 3 is re-assembled onto the Tibial IM Rod 18 for the removal of the Tibial IM Rod 18 and Tibial IM Alignment Guide 19. The Tibial Cutting Jig 21 will stay in the position. Now the proximal tibial resection may be performed utilizing a 1.27 mm saw blade. Once the resection is completed, the Cutting Guide and Pins may be removed for subsequent trial reduction. 21 Tibial Cutting Jig RE RE NOTE : Prior to resection, if the surgeon wishes to increase or decrease the tibial resection thickness, the +2 or -2 hole locations may be utilized to re-position the Tibial Cutting Jig

16 B. Tibial Preparation B.2. Tibial Extramedullary Alignment Method 22 Tibial EM Alignment Guide RA 23 Spike and Tibial EM Guide Extractor Assemble the Tibial Cutting Jig 21 to the selected Tibial EM Alignment Guide 22. With the knee fully flexed, position the distal portion of the Tibial EM Alignment Guide 22 at the anterior ankle joint with the supramalleolar spring tabs. Position the proximal portion of the Tibial EM Alignment Guide 22 by impacting the spikes of the Tibial EM Alignment Guide 22 into the central portion of the proximal tibial plateau. The cutting amount may be determined by inserting the Tibial Stylus 20 in the resection slot. NOTE : The Tibial Stylus 20 allows two options for to position the Cutting Guide; 2 mm or 9 mm cutting levels. When the Tibial Stylus 20 tip marked 2 mm is positioned on the low point of the tibial plateau, the bone resection will occur 2 mm below the contact point of the stylus tip. If the 9 mm stylus tip is positioned on the high point of the tibial plateau, it will position the Tibial Cutting Jig 21 9 mm below the contact point of the stylus tip. Once the elevation is chosen, the 3.2 mm Twist Drills 11 are placed in the 0 hole option of the Tibial Cutting Jig 21. Additional peripheral Drills 11 or Spike 8 may also be used to secure the Tibial Cutting Jig 21. Once the Tibial Cutting Jig 21 is securely positioned, the Tibial EM Alignment Guide 19 may now be removed by utilizing the Spike and Tibial EM Guide Extractor 23. Resection of the tibial plateau is now performed by using a 1.27 mm saw blade. NOTE : Prior to resection, if the surgeon wishes to increase or decrease the tibial resection thickness, the +2 or -2 hole locations may be utilized to re-position the Tibial Cutting Jig

17 B. Tibial Preparation 14

18 24 Gap Gauge B. Tibial Preparation B.3. Extension and Flexion Gap Confirmation The flexion and extension joint space gaps may be evaluated at this time with the Gap Gauge 24. The 9 mm Gap Gauge 24 is initially selected to assess both the flexion and extension joint space. If a thicker gap is required, combine additional Gap Gauge 24 blocks with different thicknesses and test again. The range of thickness is from 9 mm to 18 mm. If neither the flexion and extension gaps nor soft tissue tension shows any problem, insert the femoral trial and the tibial trial to test the knee mobility and their relative positions. NOTE : The Alignment Rod 3 may be inserted through the Gap Gauge 24 handle to assess the extramedullary alignment in both flexion and extension. 15

19 B. Tibial Preparation If the flexion, extension, or both gaps and associated soft tissue tension appear to be unbalanced, the following techniques may be employed : Tight Flexion - Tight Extension : Resect Additional Bone from the Tibia If the gap is deemed too tight in both flexion and extension, the surgeon may wish to remove additional bone from the tibia, as it is the common surface to both flexion and extension gaps. The surgeon may re-position the Tibial Cutting Jig 21 to perform this resection. The Gap Gauge 24 may then be utilized to re-access the newly established flexion/extension gap. Balanced Flexion - Tight Extension : Resect Additional Bone from the Distal Femur If the gap is deemed too tight in extension only, the surgeon may wish to remove additional bone from the distal femur, as recutting this surface will only affect the extension gap only. The Distal Femoral Cutting Guide 10 may be repositioned on the femur to performthis resection. Then the Gap Gauge 24 may be utilized to re-access the flexion/extension gap. NOTE : Following the distal femoral recuting, the AP-Chamfer Cutting Guide 15 is required to recreate the femoral chamfer cuts. Tight Flexion - Balanced Extension : Resect Additional Bone from the Posterior Femur If the Gap Gauge 24 is too tight in flexion only, the surgeon may elect to down-size the femoral component and thereby affect the associated flexion gap only. To down-size the femoral component, select an AP-Chamfer Cutting Guide 15 the is one size smaller than the originally used, and reposition the guide into the original distal femoral drill holes. 16

20 25 Femoral Trial, CR C/N various by size C. Trial Reduction for MBC Knee C.1 Femoral Trial Insertion Assemble the CR Femoral Trial 25 to the Femoral Driver 26. Center CR Femoral Trial 25 at the femoral intercondylar notch and hit it onto the resected femur with the Femoral Impactor 27. Perform with great care and pay special attention to make sure that it is aligned with the mechanical axis and rested flush against the bone cutting surface. Drill the fixation peg holes with the Femoral Condyle Drill Femoral Driver RB 27 Femoral Impactor RB 28 Femoral Condyle Drill

21 C. Trial Reduction for MBC Knee C.2 Tibial Baseplate Sizing In the U2 MBC knee system, the femoral component and the insert should be in the same size, and the mating tibial baseplate should not be more than one size down to avoid overhanging while rotating. Choose an appropriate size MB Tibial Baseplate Trial 28 and obtain the maximal coverage area without overhanging the bone cutting surface. After determining the size, attach the MB Tibial Baseplate Trial 28 to the Tibial Baseplate Trial Handle 29 and place the assembly on the cutting surface. Alternatively, insert an Alignment Rod 3 in the guide hole on the Tibial Baseplate Trial Handle 29 and have the rod parallel to the tibial axis and its distal end aligned with the second toe as a reference for tibial baseplate position. 28 MB Tibial Baseplate Trial Tibial Baseplate Trial Handle Component Size Pairing Table Femur Insert Baseplate #1 #2 #3 #4 #5 #6 #1 #1 #2 #2 #3 #3 #4 #4 #5 #5 #6 #6 18

22 30 Tibial Drill Guide RF 31 Tibial Drill C. Trial Reduction for MBC Knee C.3. Creating Stem Space for Tibial Baseplate Fix the MB Tibial Baseplate Trial 28 on the tibia with Spikes 8. Attach the Tibial Drill Guide 30 to it and drill an opening with the Tibial Drill 31. Choose a corresponding size MB Tibial Punch 33 and attach it to a MB Tibial Punch Handle 32. Position the Handle to the guide hole on the MB Tibial Baseplate Trial 28 and to ensure that the MB Tibial Punch 33 hits precisely and vertically into the tibial canal. Detach tibial punch from the Handle, leave the MB Tibial Punch 33 in the canal for following trial reduction. Then remove the spikes. 32 MB Tibial Punch Handle RC 33 MB Tibial Punch

23 C. Trial Reduction for MBC Knee C.4. Trial Reduction The MB Tibial Punch 33 allows the baseplate trial to be fixed in place. Locate the CR Femoral Trial 27 and choose a MBC Tibial Insert Trial 34 with a proper thickness and place it on the Tibial Punch 33. Examine the relativity, mobility and stability of the knee with great care. 34 Tibial Insert Trial, MBC C/N various by size 20

24 D. Patellar Preparation 35 Caliper Patellar Sizing Ring There are two options for patellar component: Inset and Onset. D.1. Inset Patellar Component Preparation Evert the patellar and remove excessive osteophytes. With a Caliper 35, measure and record the thickness of the anterior-posterior dimension of the patella. NOTE : In planning the resection thickness, it is recommended to retain a 10 mm minimal thickness of retained patella bone to support the implant structure. The Patellar Sizing Ring 36 is used to determine the desired patellar diameter and positioning. Typically, the Ring is positioned over the highest point of the articulation and the center position is marked with a cautery or ink. 2mm 21

25 D. Patellar Preparation D.1.1. Inset Patellar Reaming Depth and Pilot Hole Attach the Patellar Clamp Ring 37 to the Resection Clamp 38 of the chosen size. Center the Ring at the highest position of the patella and clamp the patella for fixation. Place a Patellar Drill Depth Sleeve 39 on the clamp ring. Direct the Patellar Reamer 40 downwards into the Ring, with its tip touching the highest point of patellar. Place Patellar Reamer Stopper 41 level on the sleeve and tighten the stopper with a Screw Driver 42. Then make sure that the drill depth of the reamer equals that of the patellar component thickness. Remove the sleeve and insert a Patellar Drill Guide 43 of the same size. Next, use the Patellar Drill 44 to create the pilot hole for the patellar component. Once the drilling is completed, the Patellar Reamer 40 is reintroduced into the Patellar Clamp Ring 37 for creating the inset patellar bed. NOTE: If the thickness of patella is smaller than 20 mm, it will be necessary to adjust the stopper manually to the desired drill depth to retain at least 8 mm patellar thickness. 37 Patellar Clamp Ring C/N various by size 38 Patellar Resection Clamp RB 39 Patellar Drill Depth Sleeve C/N various by size 40 Patellar Reamer C/N various by size 41 Patellar Reamer Stopper Screw Driver Patellar Drill Guide C/N various by size 44 Patellar Drill

26 45 Inset Patellar Trial D. Patellar Preparation D.1.2. Drill Hole Completion and Trial Installation Now the Patellar Resection Clamp 38 is removed and the Inset Patellar Trial 45 is the position of the prepared bone bed. The peripheral bone shoulder surrounding the inset patellar trial is accessed, and may be trimmed to achieve a smooth blending of the implant periphery to the boney shoulder. 23

27 D. Patellar Preparation D.2. Onset Patellar Component Preparation When the Onset patellar component is choosed, assemble the Onset Patellar Resection Guide 46 to the Patellar Resection Clamp 38. Use the stylus on the bottom of onset patellar resection guide to check if the remained patellar thickness exceeds 10 mm. If so, clamp the patella tight and place the saw blade into the slot of the clamp and resect the patella until the showing subchondral bone. Then choose the appropriate size Onset Patellar Drill Guide 47, and drill three round fixation peg holes with the Onset Patellar Peg Drill 48. Now the preparation for onset patellar component is completed. Now the Onset Patellar Trial 49 may be positioned. Assessing the contact and stability of the bone/implant couple. A thickness measurement of the implant/bone couple may be performed to assure the original patellar A-P thickness. Trialing is performed in a standard fashion. 46 Onset Patellar Resection Guide RB 47 Onset Patellar Drill Guide RA RA RA RA RA RA RA 48 Onset Patellar Peg Drill Patellar Trial, Onset

28 E. Implant Fixation E.1. Final Trial Reduction Apply the patellar trial, femoral trial, tibial baseplate trial, and tibial insert trial to the corresponding resected bony surfaces. Test for the joint laxity and range of motion, and observe how muscles and ligaments react at extension and flexion. If it is too loose or too tight, adjust the soft tissue tension to ensure that both joint stability and mobility are ideal. After the testing is done, remove all trials and clean the cutting surface. 25

29 E. Implant Fixation E.2. Implant Fixation Tibial Component Apply bone cement onto the tibial component. Place the tibial baseplate manually with great care. When there is only 2-3 mm left, hit it into the canal with a Tibial Baseplate Impactor 50. Make sure it aligns tibial axis during the process. Patellar Component Apply bone cement onto the patellar component. Clamp with a Patellar Cement Clamp Adapter 51 until the bone cement hardens. Femoral Component Apply bone cement onto the femoral component. Assemble the chosen femoral component to the Femoral Driver 26. Aim the assembly at the previously prepared cutting and hit it onto the femur. Tibial Insert Attach the MB Tibial Insert Trial Adapter 52 to the mobile bearing tibial insert trial, put the assembly into the central hole on the tibial baseplate. Keep the knee in extention for pressurization till cement harden. Confirm the mobility and stability, then insert the corresponding tibial insert into the tibial baseplate. 50 Tibial Baseplate Impactor RF 51 Patellar Cement Clamp Adapter RD 52 MB Tibial Insert Trial Adapter

30 U2 Femoral Component, CR Size AP ML Inset Patellar Component 27 AP ML Onset Patella Component Inset Patella Component Size Thickness Diameter S 8 22 M L XL Size Thickness Diameter XS 7 26 S 8 29 M L 9 35 XL XXL EL Size S M L XL UHMWPE XPE E-XPE Diameter Thickness Diameter Thickness Special Order Items Size XS S M L XL 2XL 3XL UHMWPE XPE E-XPE Size #1 #2 #3 #4 #5 #6 Left Right Left Porous CR Right Cemented CR

31 28 U2 Tibial Baseplate, MB Size AP ML Size #1 #2 #3 #4 #5 #6 MB Tibial Insert, MBC Size #1 #2 #3 #4 #5 #6 9mm mm UHMWPE 13mm mm mm Size #1 #2 #3 #4 #5 #6 9mm mm E-XPE 13mm mm mm

32 Instrument Catalog Femoral Trial, CR, Left, #1 Femoral Trial, CR, Left, #2 Femoral Trial, CR, Left, #3 Femoral Trial, CR, Left, #4 Femoral Trial, CR, Left, #5 Femoral Trial, CR, Left, #6 Femoral Trial, CR, Left, #7 Femoral Trial, CR, Right, #1 Femoral Trial, CR, Right, #2 Femoral Trial, CR, Right, #3 Femoral Trial, CR, Right, #4 Femoral Trial, CR, Right, #5 Femoral Trial, CR, Right, # Tibial Baseplate Trial, MB, #1 Tibial Baseplate Trial, MB, #2 Tibial Baseplate Trial, MB, #3 Tibial Baseplate Trial, MB, #4 Tibial Baseplate Trial, MB, #5 Tibial Baseplate Trial, MB, # Tibial Insert Trial, MBC, #1, 9 mm Tibial Insert Trial, MBC, #1, 11 mm Tibial Insert Trial, MBC, #1, 13 mm Tibial Insert Trial, MBC, #1, 15 mm Tibial Insert Trial, MBC, #1, 18 mm Tibial Insert Trial, MBC, #2, 9 mm Tibial Insert Trial, MBC, #2, 11 mm Tibial Insert Trial, MBC, #2, 13 mm Tibial Insert Trial, MBC, #2, 15 mm Tibial Insert Trial, MBC, #2, 18 mm Tibial Insert Trial, MBC, #3, 9 mm Tibial Insert Trial, MBC, #3, 11 mm Tibial Insert Trial, MBC, #3, 13 mm Tibial Insert Trial, MBC, #3, 15 mm Tibial Insert Trial, MBC, #3, 18 mm Tibial Insert Trial, MBC, #4, 9 mm Tibial Insert Trial, MBC, #4, 11 mm Tibial Insert Trial, MBC, #4, 13 mm Tibial Insert Trial, MBC, #4, 15 mm Tibial Insert Trial, MBC, #4, 18 mm Tibial Insert Trial, MBC, #5, 9 mm Tibial Insert Trial, MBC, #5, 11 mm Tibial Insert Trial, MBC, #5, 13 mm Tibial Insert Trial, MBC, #5, 15 mm Tibial Insert Trial, MBC, #5, 18 mm Tibial Insert Trial, MBC, #6, 9 mm Tibial Insert Trial, MBC, #6, 11 mm Tibial Insert Trial, MBC, #6, 13 mm Tibial Insert Trial, MBC, #6, 15 mm Tibial Insert Trial, MBC, #6, 18 mm

33 Instrument Catalog Patellar Trial, Inset, S, Ø 22 mm Patellar Trial, Inset, M, Ø 25 mm Patellar Trial, Inset, L, Ø 28 mm Patellar Trial, Inset, XL, Ø 32 mm Patellar Trial, Onset, XS, Ø 26 mm Patellar Trial, Onset, S, Ø 29 mm Patellar Trial, Onset, M, Ø 32 mm Patellar Trial, Onset, L, Ø 35 mm Patellar Trial, Onset, XL, Ø 38 mm Patellar Trial, Onset, 2XL, Ø 41 mm Patellar Trial, Onset, 3XL, Ø 43 mm T-Handle RB Starter Lower Point Gauge, 1.3 mm 30

34 Instrument Catalog Extramedullary Alignment Tower Femoral A/P Chamfer Guide Handle mm Twist Drill Spike, Short Bone File 31

35 Instrument Catalog RA Femoral IM Alignment Guide RA Distal Femoral Alignment Guide RC Distal Femoral Cutting Guide RC RC RC RC RC RC Femoral A/P Chamfer Cutting Guide #1 Femoral A/P Chamfer Cutting Guide #2 Femoral A/P Chamfer Cutting Guide #3 Femoral A/P Chamfer Cutting Guide #4 Femoral A/P Chamfer Cutting Guide #5 Femoral A/P Chamfer Cutting Guide # Femoral IM Rod, 400 mm 32

36 Instrument Catalog Spike, Short Spike, Long Ø 3.2 mm Twist Drill, Short Ø 3.2 mm Twist Drill, Long Round Pin,Ø 3.2x120 mm Femoral Condyle Drill RA Quick Pin Driver 33

37 Instrument Catalog Pin Extractor Spike and Tibial EM Guide Extractor RB Femoral Impactor RB Femoral Driver RE Femoral Sizer, Anterior Ref. 34

38 Instrument Catalog RA RA Tool Box U2 Knee Case #1 Tool Box U2 Knee Case #3 Tool Box U2 Knee Case #4 Tool Box U2 MBC Case Tibial IM Rod Patellar Reamer, S Patellar Reamer, M Patellar Reamer, L Patellar Reamer, XL Patellar Reamer Stopper Patellar Drill Depth Sleeve, S Patellar Drill Depth Sleeve, M Patellar Drill Depth Sleeve, L Patellar Drill Depth Sleeve, XL 35

39 Instrument Catalog Patellar Drill RB Patellar Resection Clamp RA RA RA RA Patellar Clamp Ring, S Patellar Clamp Ring, M Patellar Clamp Ring, L Patellar Clamp Ring, XL Screw Driver Patellar Drill Guide, S Patellar Drill Guide, M Patellar Drill Guide, L Patellar Drill Guide, XL 36

40 Instrument Catalog RD Patellar Cement Clamp Adapter Inset Patellar Sizing Ring Caliper RC Tibial Punch Handle, MB Tibial Baseplate Trial Handle 37

41 Instrument Catalog Special Order Items RA Tibial IM Alignment Guide RA Tibial EM Alignment Guide RF Tibial Drill Guide RE RE RE RE Tibial Cutting Jig, 0 Left Tibial Cutting Jig, 5 Left Tibial Cutting Jig, 0 Right Tibial Cutting Jig, 5 Right Alignment Rod 38

42 Instrument Catalog Tibial Drill Onset Patellar Peg Drill RF Tibial Baseplate Impactor MB Tibial Insert Trial Adapter RB Onset Patellar Resection Guide 39

43 Instrument Catalog RA RA RA RA RA RA RA Onset Patellar Drill Guide, Ø 26 mm Onset Patellar Drill Guide, Ø 29 mm Onset Patellar Drill Guide, Ø 32 mm Onset Patellar Drill Guide, Ø 35 mm Onset Patellar Drill Guide, Ø 38 mm Onset Patellar Drill Guide, Ø 41 mm Onset Patellar Drill Guide, Ø 43 mm Tibial Punch, MB, S Tibial Punch, MB, M Tibial Punch, MB, L Gap Gauge, 9 mm Gap Gauge, 11 mm Gap Gauge, 13 mm Gap Gauge, 15 mm Gap Gauge, 18 mm RA Tibial Stylus 40

44 U2 Mobile Bearing Knee System Safety statement DESCRIPTION The U2 Mobile Bearing Knee System include femoral components, patellar components, tibial trays and tibial inserts which are designed to be used together to achieve total replacement of the knee joint. These components are available without porous coating. The femoral components are posterior stabilized designs. The tibial tray components has groove for cement fixation. Tibial inserts are available in a range of thicknesses and freely rotated with metallic tibial baseplate. Posterior Stabilized inserts have raised tibial eminence for increased anterior and posterior constraint, prevention of posterior subluxation and varus/valgus stability. The patellar components are available in all plastic in-set and on-set designs with dome shape configurations. Materials: ASTM F75 Co-Cr-Mo alloy ISO UHMWPE Femoral component, Tibial baseplate Tibial insert, Patella INDICATIONS The U2 Mobile Bearing Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is indicated for moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. CONTRAINDICATIONS The U2 Mobile Bearing Knee System is contraindicated in patients with any active or suspected latent infection in or about the knee joint. Patients without sufficient bone stock to provide adequate support and/or fixation to the prosthesis. Patients without sufficient soft tissue integrity to provide adequate stability. Patients with either mental or neuromuscular disorders which would create an unacceptable risk of prosthesis instability or complications in postoperative care, and in patients whose weight, age or activity level might cause extreme loads on the prosthesis and early failure of the system. ADVERSE EFFECTS Potential adverse effects include infection, loosening of the components, breakage or bending of the components, or change in position of the components. Dislocation can occur due to inappropriate patient activity, trauma or other biomechanical considerations. Loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis, component malalignment, osteolysis or trauma. Breakage or bending may result due to inadequate support of the component by the underlying bone or poor component fixation. Wear of polyethylene components has occurred and literature reports have associated its occurrence with bone resorption, loosening and infection. Other potential adverse effects of total knee surgery include genitourinary disorders; gastrointestinal disorders; neurovascular damage, thromboembolic disease, myocardial infarction and other less common adverse effects. Adverse effects may necessitate reoperation, revision, arthrodesis of the involved joint, and/or amputation of the limb. Due to the many biological, mechanical and physicochemical factors which affect these devices, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone. WARNINGS AND PRECAUTIONS Familiarity with and attention to appropriate surgical Technique for total knee arthroplasty and the U2 Mobile Bearing Knee System is essential for success of the total knee procedure. Only surgeons who have reviewed the literature regarding total knee surgery and have had training in the technique should utilize the device. Patients should be instructed the limitations of the prosthesis, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly. If the patient is involved in an occupation or activity which includes substantial walking, running, lifting, or muscle strain, the resultant forces can cause failure of the fixation, the device, or both. The prosthesis will not restore function to the level expected with normal healthy bone, and the patient should not have unrealistic functional expectations. Accordingly, strict adherence to the indications, contraindications, precaution and warnings for this product is essential to potentially maximize service life. Appropriate selection, placement and fixation of the total knee components are critical factors that affect implant service life. As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic biomechanic and other extrinsic factors, which limit their service life. The surgeon must not allow damage to polished bearing surfaces because this may accelerate wear of the components. Discard all damaged or mishandled implants. Never reuse an implant. Reuse of this product will cause the risk of cross infection and unpredictable health threat. Keep bearing areas clean and free of debris prior to assembly. Components of the U2 Mobile Bearing Knee System should not be used with those of another manufacturer's total knee component since articular and dimensional compatibility cannot be assured. Intentional removal of the plastic tibial insert after its assembly into the tibial tray results in the destruction of the plastic insert. Care should be taken not to nick or notch the surface of the tibial tray during insert removal. Return all packages with flaws in the sterile barrier to the supplier. Do not resterilize. UTILIZATION AND IMPLANTATION Selection of the U2 Mobile Bearing Knee System depends on the requirement 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 total knee arthroplasty surgery. The trial components should be used for size determination, trial reduction and range of motion evaluation. Radiographic templates are available to assist in the preoperative prediction component size and style. The UHMWPE plugs may be removed from the screw holes, and bone screw may be used for additional fixation. The U2 Surgical Protocols provide procedural information. PACKAGING, LABELING AND STERILIZATION All U2 Mobile Bearing implants have been sterilized by gamma radiation. The packaging of all sterile products should be inspected for their integrity and should be accepted only with proper packaging and labeling intact. Care should be taken to prevent contamination of the component. In the event of contamination, this product must be discarded. If the package is opened, but the product is not used, the component must not be resterilized and must be discarded or returned to the supplier. 41 IMPORTANT FOR OPENED COMPONENTS The plastic components, if opened, are not permitted be re-sterilization by any method. The metal components, if opened, please return to United Orthopedic Corporation. A suitable handing in cleaning (if necessary), packaging and gamma radiation will be done.

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46 Each Step We Care Contact Us Taiwan United Orthopedic Corporation 12F, No.80, Sec.1, Chenggong Rd., Yonghe Dist., New Taipei City 23452, Taiwan Tel: Fax: China United Medical Instrument Co., Ltd. Room 402, Building 7, No.697, Ling Shi Road, ShangHai , China Tel: Fax: Japan United Biomech Japan Inc. Ginyo Bldg 4th floor, Kitasaiwai, Nishi-Ku Yokohama City, Kanagawa, , Japan Tel: Fax: USA UOC USA Inc. 20, Fairbanks, Suite 173, Irvine 92618, CA Tel: Fax: EU Representative mdi Europa GmbH Langenhagener Strasse 71, Langenhagen 30855, Germany Tel: Fax: Europe UOC (Suisse) SA Avenue Général Guisan 60A, Pully 1009, Switzerland Tel: Fax: UOC (France) 21, Rue de la Ravinelle, Nancy 54000, France Tel: Fax: Copyright 2017 United Orthopedic Corp. All rights reserved. UOC-UM-UN Rev.0 SEP. 2017