Design Rationale/Surgical Technique GRIPTION TF

Transcription

1 Design Rationale/Surgical Technique GRIPTION TF

2 Table of contents Augment, Shim, and Buttress Portfolio...4 GRIPTION TF Augments System Overview...5 GRIPTION TF Buttress System Overview...6 GRIPTION TF Shim System Overview...7 Advanced Materials...8 Advanced Fixation...10 Advanced Instrumentation...12 Advanced Modularity...14 Key Bone Stock and Landmark Considerations...15 Treatment by Defect Algorithm...16 Pre-operative Planning and Templating...17 GRIPTION TF Surgical Technique...18 Acetabular Preparation...19 Implant Insertion...22 Buttress Plate/Shim Surgical Technique...27 Ordering Information...30 References

3 GRIPTION TF Filling the gap in acetabular revision surgery Advanced Materials Advanced Instrumentation Advanced Fixation

4 GRIPTION TF Augment, Shim, and Buttress Portfolio DePuy s GRIPTION TF Acetabular Revision System is an innovative technology for addressing bone defects in complex acetabular revision surgery. It represents the latest advances in materials, fixation and instrumentation technologies. Combined with other elements of the PINNACLE Hip Solutions portfolio including the leading acetabular cup system and advanced bearing options the result is a winning solution to help restore motion for today s revision patients.

5 GRIPTION TF Augments System Overview The GRIPTION TF Augments are designed to act as a defect filling implant in the case of severe bone loss in the acetabulum. Advanced geometry provides increased surface area for bone contact. Directional screw holes engineered to maximize fixation capability. Proprietary TRUEBOND locking slot to help mechanically secure Augment to acetabular shell. Tight radius inner diameter on Augment to achieve precise fit with cup. Screwhole cutaways to optimize fit with PINNACLE Cup System. Pin holes enhance visualization & assessment of Augment fit and suitability. 5

6 GRIPTION TF Buttress System Overview The GRIPTION TF Buttress is designed to support the shell in a similar manner as the Augments, however the Buttress implant spans the defect in the acetabulum and is cemented to the shell. Tapered curved surface for ease of implantation Screw holes for use with 5.5mm locking/non-locking cortical screws Screw holes for use with 6.5mm cancellous screws Curved spherical radius to mate with Acetabular Shell 6 Neutral, left and right configurations available for different implant positioning

7 GRIPTION TF Shim System Overview The GRIPTION TF Shim implants are designed to mate with the Buttress to raise the end of the Buttress when pelvic geometries require support. Available in 5, 10 and 15-degree configurations Oversized holes for clearance of locking/ non-locking screws

8 Advanced Materials The GRIPTION TF material is a completely porous structure made from commercially pure titanium. It provides a modulus of elasticity similar to bone, and a coefficient of friction that allows for initial scratch fit. Advanced Materials Advanced Instrumentation Advanced Fixation Coefficient of Friction GRIPTION TF Augments 1 Zimmer Augments 2

9 Bone-like Modulus of Elasticity GPa GRIPTION TF 1 Zimmer 4 Cortical Bone Cancellous Bone Compressive Yield Strength MPa GRIPTION TF Augments 1 Zimmer Augments 3 9

10 Advanced Fixation Locking Screw Option GRIPTION TF implants have the ability to use locking screws to fixate the Augment or Advanced Materials Buttress to the cup and bone. Locking screws help prevent the screw from becoming loose Advanced Instrumentation Advanced Fixation and backing out of the Augment and cup. This helps eliminate the risk of compromising the fixation as a result of screw migration. In addition, GRIPTION TF allows surgeons to implant diverging locking screws for even stronger fixation to the host bone. 10

11 Cement, Cementless or Hybrid Fixation Options Prior to the availability of the GRIPTION TF Augments, the only method of fixating the Augment to the cup was with bone cement. The introduction of the GRIPTION TF Augments allow surgeons to select between cementless, cemented and hybrid options of Augment to cup fixation. TRUEBOND Cementless Technology Hybrid Fixation Cemented

12 Advanced Instrumentation The DePuy GRIPTION TF Revision System is the only Augment and Buttress system that provides specialized instruments to prepare a customized bone Advanced Materials envelope for the GRIPTION TF implants. The GRIPTION TF Advanced Instrumentation Advanced Fixation Revision System allows surgeons to select two methods of preparing the acetabular bone with their choice of modular or finishing rasps. Featuring easy connect technology, the GRIPTION TF system-specific instruments are user-friendly and innovative, making them a valuable complement to your technique.

13 Finishing rasp Modular rasp 13

14 Advanced Modularity The DePuy GRIPTION TF Augments and Buttresses are compatible with the PINNACLE Hip Solutions Acetabular system. The PINNACLE Hip Solutions provide the largest selection of advanced bearing technologies, biological and mechanical Bantam 38-46mm fixation alternatives. With more implant designs and choices than any competitive system, you ll never have to compromise when meeting the individual needs of patients. 100 series 44-66mm DuoFix Gription* Sector 48-66mm Porocoat AltrX Ultamet Porocoat Marathon Marathon Multi-Hole 48-72mm Gription Ultamet asphere M-Spec BIOLOX delta AltrX DuoFix* Revision 54-80mm DuoFix AltrX Standard Metal M-Spec Ultamet Gription Marathon Deep Profile 54-72mm Porocoat Marathon AltrX Porocoat Gription DuoFix 14

15 Key Bone Stock and Landmark Considerations Radiographic landmarks can be helpful in assessing the acetabular bone stock. It can also be useful to order a CT scan of the area with a metal suppression technique. A CT scan will often indicate significantly more lysis than what is apparent on plain radiographs, and can also aid in determining pelvic discontinuities or loss of structural bone. Bone Stock Considerations Completely supportive acetabulum PINNACLE Hip Solutions Shell Partially supportive acetabulum PINNACLE Hip Solutions Shell with GRIPTION TF Augments Non-supportive PINNACLE Hip Solutions Shell with possible need for Augment, Buttress or cage Anatomic landmarks 1. Acetabular teardrop integrity of medial wall and inferior portion of anterior and posterior column 2. Kohler s line integrity of medial wall and superior anterior column 3. Ischial lysis integrity of posterior wall and posterior column

16 Possible Surgical Solutions by Defect Classification The Paprosky Classification is the most widely used defect classification. 5 Type 1 anterior/posterior columns are intact and supportive Greater than 70 percent of host bone to hemispherical shell contact Type 2A anterior/posterior columns are intact and supportive Superior migration less than 2cm Up to 30 percent of the cup may be uncovered superiorly Type 2B Superior migration less than 2cm anterior/posterior columns are supportive Greater than 50 percent of host bone to hemispherical shell contact Type 2C Rim is intact but distorted Medial wall defect and superior head center migration (<2cm) Teardrop is obliterated Type 3A percent of rim unsupportive Greater than 2cm superior migration less than 50 percent of host bone to hemispherical shell contact Type 3B Greater than 60 percent of rim unsupportive Significant lysis and loss of posterior column bone stock Risk of pelvic discontinuity

17 Surgical Technique Pre-operative Planning and Templating Using the standard DePuy PINNACLE acetabular shell templates, the surgeon can determine the approximate size of the revision shell that may be required, including the possibility of jumbo cups (>66mm diameter), deep profile cups, or acetabular Augments. Assessing the acetabular bone stock is of great importance in helping the surgeon to anticipate the possible structural defects that may be encountered during the surgery. 17

18 GRIPTION TF Surgical Technique Once the acetabulum has been exposed and evaluated preparation for the acetabular construct can begin. Start by reaming the acetabulum with an undersized reamer at a level that will restore the appropriate center of rotation. Ream concentrically with progressively larger reamers maintaining appropriate opening abduction and anteversion. Reaming should stop when adequate rim contact has been obtained excluding the defect region. At this point, the surgeon has 3 options for preparing the acetabular defect to accept the GRIPTION TF Augment: Finishing Rasp Modular Rasp Free hand Technique 18

19 Acetabular Preparation Finishing Rasp Technique Once the acetabular cavity has been prepared, place the hemispherical acetabular trial into the prepared bed at the correct center of rotation. Choose the appropriately sized finishing rasp and start preparing the acetabular defect by keeping the inside diameter of the finishing rasp against the outer surface of the acetabular trial. Advance the rasp slowly until the desired seating level is obtained. If it appears that there is not intimate bone contact with the rasp, increasing to the next size of rasp may be necessary, repeating the steps above until adequate bone contact has been obtained. Once the defect has been prepared satisfactorily, tap the appropriate GRIPTION TF Augment trial into place. If the trial is stable, then the defect is appropriately prepared. If adequate bone contact is not obtained, or the trial is not stable, further preparation with larger rasps may be needed. If the defect is such that adequate bone contact and stability cannot be obtained, then consideration should be given to utilizing a GRIPTION TF Buttress to span the defect or possibly inverting the acetabular Augment and using it as a Buttress.

20 Acetabular Preparation Continued Modular Rasp Technique Once the acetabular cavity has been prepared, utilize the half shell trial that is undersized by 1mm from the last reamer or acetabular trial that was used. Place the trial in the prepared acetabular cavity at the correct center of rotation. Attach the modular rasp to the dovetail of the trial and rotate the construct so that the rasp will prepare the defect appropriately. Starting with the smallest size rasp, prepare the defect utilizing progressively larger rasps until the defect has been satisfactorily prepared to accept the appropriate size Augment. Remove the half shell trial and insert the appropriate full hemispherical acetabular trial. The GRIPTION TF Augment trial can now be placed into the defect and can be tapped into place. If the trial is stable, the defect is appropriately prepared. If adequate bone contact is not appreciated or the trial is not stable, then further preparation with larger rasps may be needed. If the defect is such that adequate bone contact and stability cannot be obtained, then consideration should be given to utilizing a GRIPTION TF Buttress to span the defect.

21 Once appropriate stability has been obtained for the Augment trial, the real Augment is ready to be placed. Free Hand Technique Once the acetabular cavity has been prepared, a hand held burr can be utilized to prepare and shape the remaining acetabular defect in order to accommodate the GRIPTION TF Augment trial. Care should be taken to remove only the minimum amount of bone necessary to accommodate the trial Augment. Frequently test the defect to avoid unnecessary bone removal using the trial. 21

22 Implant Insertion Once the acetabulum and the acetabular defect have been prepared to accept the acetabular shell and Augment, the surgeon can decide to place either the shell first and then the Augment, or the Augment can be placed initially and the shell placed secondarily. In addition, at the time of insertion of the shell and Augment, the surgeon should decide whether cement fixation or mechanical fixation will be utilized to join the Augment to the acetabular shell. It is important at the time of shell insertion to orient the shell appropriately so that a screw can be placed through one of the screw holes in the shell and also through the fixation slot in the Augment if mechanically mating. Acetabular Shell-First Technique After preparation of the acetabulum and Note: Acetabular shells should be placed at 45 degrees of abduction and 15 degrees of anteversion. accompanying defect has been completed, insert the acetabular shell in accordance with the PINNACLE Acetabular Cup system technique. 22

23 Acetabular Shell-First Technique, Continued Tip: Use the 3.8 drill bit for the 6.5mm cancellous screws. Use the 3.8 drill bit for the 5.5mm locking screw. If using 5.0 screw, use the 3.2 drill bit which is utilized with the PINNACLE Revision System. Screws for supplemental fixation may be placed at this point if necessary. The surgeon should pay close attention to any shift in position of the shell that may occur secondary to placing and tightening down the screws. If the shell requires placement of the Augment to provide stability of the construct, tightening the screws before placing the Augment may shift the shell slightly. This may cause difficulty in placing the Augment if the acetabular defect has been prepared in a precise manner. If a shift in position of the acetabular shell is noted, the screws should be backed out slightly to allow the appropriate placement of the Augment and then re-tighten. If the shell is stable without initial screw fixation the screws can be placed after the Augment has been inserted. Once the acetabular shell is in place, if cement mating of the two components is desired, a bead of doughy cement should be placed on the outer surface of the shell prior to placing the Augment. The Augment inserter tip should be placed on the flat surface of the Augment in the two center holes. The Augment can then be tapped into place behind the acetabular shell and into the prepared defect.

24 Implant Insertion Continued Acetabular Shell-First Technique, Continued Additional screw fixation of the Augment can then be performed. The knurled, threaded pins can be used to help stabilize the Augment during screw insertion if necessary. Alternatively, the surgical assistant can stabilize the Augment with the inserter tip until provisional screw fixation is obtained. Tapered head, 5.5mm locking or 5.0mm non-locking screws should then be placed utilizing the standard technique. If mechanical mating of the shell and Augment is desired, then once the shell and Augment are in place, a standard PINNACLE 6.5mm screw can be placed through the shell and the fixation slot of the Augment. Special care should be taken to ensure that the head of the screw is fully seated within the acetabular shell. Tip: Use the 3.8 drill bit for the 6.5mm cancellous screws. Use the 3.8 drill bit for the 5.5mm locking screw. If using 5.0 screw, use the 3.2 drill bit which is utilized with the PINNACLE Revision System.

25 Augment-First Technique After the preparation of the acetabulum and accompanying defect has been completed, the acetabular Augment can now be placed. Using the Augment 90-degree inserter tip, place the inserter into the holes on the inside diameter of the Augment. The Augment can now be impacted into the defect or held in place with the inserter. Insert the knurled, threaded pins through the holes in the flat face of the Augment to provide provisional fixation. Screw fixation utilizing either 5.5mm locking or 5.0 mm non-locking screws can now be performed. If desired, supplemental fixation utilizing the inside diameter holes of the Augment can now be performed as well. Special care should be taken to ensure that the screw heads are fully seated and flush or countersunk slightly when utilizing the inner diameter fixation holes. Tip: For pre-drilling the inner diameter screw, the angled 45-degree drill bit may be easier to use than a straight drill bit. 25

26 Implant Insertion Continued Augment-First Technique, Continued If cement mating of the shell and Augment is desired, a bead of doughy cement can now be placed on the inner diameter of the Augment and the acetabular shell can be impacted in the standard fashion. Supplemental screw fixation of the shell can now be undertaken in the standard fashion. If hybrid mating of the shell and Augment is also desired, the shell should be carefully positioned during impaction so that the fixation slot of the Augment lines up with an appropriate dome hole in the acetabular shell. The shell should be impacted utilizing the standard PINNACLE acetabular cup surgical technique. Once the shell is in position, supplemental screw fixation of the shell can be carried out in the standard fashion. Additional 6.5mm screws may be placed through the appropriate dome hole in the shell and through the fixation slot in the Augment. Special care should be taken to ensure that this screw head is fully seated within the inside diameter of the shell. Tip: 26 Bone wax on the tip of the inserter may assist holding the Augment on the inserter device.

27 Buttress/ Shim Surgical Technique In some cases, the acetabular defect will require a Buttress rather than a simple acetabular Augment in order to provide appropriate stabilization of the acetabular construct. Once this has been determined, exposure of the iliac wing is required. In most cases a large elevator can be used to subperiosteally elevate the abductor musculature from the ilium to adequately allow placement of the Buttress in the correct position. In cases where exposure is difficult it may be necessary to perform some type of trochanteric osteotomy or trochanteric slide or a variant thereof to aid in exposure of the iliac wing in the supra-acetabular area. The initial preparation of the acetabulum should be carried out as noted above in the technique for the standard Augment. A hemishpherical trial should then be inserted. Different Buttress trials should then be evaluated to see which configuration straight, anterior column or posterior column best addresses the defect. Since pelvic geometries differ significantly, shims can be trialed as well to help position, raise and angulate the Buttress so that it accommodates both the defect and its apposition to the acetabular shell optimally. The shim trials snap onto the Buttress trials to aid in the ease of trialing, especially in Tip: Select screws that are longer than the combined thickness of the Buttress and Shim. the face of a difficult exposure. The shims can be oriented in 90 degree increments since the screw holes in the shims match up with those in the Buttress.

28 Buttress/ Shim Surgical Technique Continued It should be noted that, since the Buttress does not have to be in intimate contact with the acetabular shell being used, a Buttress which is smaller or larger than the acetabular shell can be utilized if they appear to provide a more appropriate fit. Buttress Insertion Once the appropriate position of the Buttress has been determined, the surgeon has the choice of which to implant first: the acetabular shell or the Buttress. If the acetabular shell is placed first, it is impacted in the standard fashion and supplemental screw fixation is utilized if necessary. If a shim is to be utilized on the Buttress, the two components must be cemented together utilizing bone cement in a doughy phase with the shim in the same position in which it was trialed. Care should be taken to remove any excess cement from the fixation holes in the shim and Buttress. Once the cement has hardened, a bead of cement should be placed on the surface of the acetabular shell which will abut the contact area of the Buttress. Again, the Buttress does not have to make intimate contact with the shell if leaving a small gap results in a better fit.

29 Buttress Insertion, Continued The Buttress construct can then be placed and held in position with the knurled, threaded guide pins while screw fixation is being performed or alternatively it can be held manually. 6.5mm screws are then utilized in the two holes closest to the acetabular shell and either 5.5mm locking or 5.0mm non-locking screws can be utilized in the 4 holes that are more proximal. The distal holes of the Buttress allow for divergent placement of the screws to aid in obtaining the best bony fixation possible. Alternatively, if the Buttress is to be placed first, the above technique can be utilized as well. Once the Buttress has been anchored, a bead of cement is placed on the contact area of the Buttress and the acetabular shell is then inserted utilizing the standard technique. Care should be taken when inserting screws into the Buttress plate to avoid potential neurovascular injury. 29

30 GRIPTION TF Augments Catalog Code Description GRIPTION TF Augment size 50/52 x GRIPTION TF Augment size 54/56 x GRIPTION TF Augment size 58/60 x GRIPTION TF Augment size 62/64 x GRIPTION TF Augment size 66/68 x GRIPTION TF Augment size 70/72 x GRIPTION TF Augment size 50/52 x GRIPTION TF Augment size 54/56 x GRIPTION TF Augment size 58/60 x GRIPTION TF Augment size 62/64 x GRIPTION TF Augment size 66/68 x GRIPTION TF Augment size 70/72 x GRIPTION TF Augment size 50/52 x GRIPTION TF Augment size 54/56 x GRIPTION TF Augment size 58/60 x GRIPTION TF Augment size 62/64 x GRIPTION TF Augment size 66/68 x GRIPTION TF Augment size 70/72 x GRIPTION TF Augment size 50/52 x GRIPTION TF Augment size 54/56 x GRIPTION TF Augment size 58/60 x GRIPTION TF Augment size 62/64 x GRIPTION TF Augment size 66/68 x GRIPTION TF Augment size 70/72 x 30 GRIPTION TF Buttress 30 Catalog Code Description GRIPTION TF Buttress 56 Neutral GRIPTION TF Buttress 56 Left GRIPTION TF Buttress 56 Right GRIPTION TF Buttress 62 Neutral GRIPTION TF Buttress 62 Left GRIPTION TF Buttress 62 Right GRIPTION TF Buttress 68 Neutral GRIPTION TF Buttress 68 Left GRIPTION TF Buttress 68 Right

31 GRIPTION TF Shims Catalog Code Description GRIPTION TF Shim 5 Degrees GRIPTION TF Shim 10 Degrees GRIPTION TF Shim 15 Degrees GRIPTION TF Instruments Case One: Trial Case Catalog Code Description mm LOCKING SCREW CADDY Catalog Code Description GRIPTION TF Augment size 50/52 x 10 Trial GRIPTION TF Augment size 54/56 x 10 Trial GRIPTION TF Augment size 58/60 x 10 Trial GRIPTION TF Augment size 62/64 x 10 Trial GRIPTION TF Augment size 66/68 x 10 Trial GRIPTION TF Augment size 70/72 x 10 Trial GRIPTION TF Augment size 50/52 x 15 Trial GRIPTION TF Augment size 54/56 x 15 Trial GRIPTION TF Augment size 58/60 x 15 Trial GRIPTION TF Augment size 62/64 x 15 Trial GRIPTION TF Augment size 66/68 x 15 Trial GRIPTION TF Augment size 70/72 x 15 Trial GRIPTION TF Augment size 50/52 x 20 Trial GRIPTION TF Augment size 54/56 x 20 Trial GRIPTION TF Augment size 58/60 x 20 Trial GRIPTION TF Augment size 62/64 x 20 Trial GRIPTION TF Augment size 66/68 x 20 Trial GRIPTION TF Augment size 70/72 x 20 Trial GRIPTION TF Augment size 50/52 x 30 Trial GRIPTION TF Augment size 54/56 x 30 Trial GRIPTION TF Augment size 58/60 x 30 Trial GRIPTION TF Augment size 62/64 x 30 Trial GRIPTION TF Augment size 66/68 x 30 Trial GRIPTION TF Augment size 70/72 x 30 Trial

32 GRIPTION TF Instruments Case One: Trial Case Catalog Code Description GRIPTION TF Buttress 56 Neutral Trial GRIPTION TF Buttress 56 Left Trial GRIPTION TF Buttress 56 Right Trial GRIPTION TF Buttress 62 Neutral Trial GRIPTION TF Buttress 62 Left Trial GRIPTION TF Buttress 62 Right Trial GRIPTION TF Buttress 68 Neutral Trial GRIPTION TF Buttress 68 Left Trial GRIPTION TF Buttress 68 Right Trial GRIPTION TF Shim Trial 5 Degrees GRIPTION TF Shim Trial 10 Degrees GRIPTION TF Shim Trial 15 Degrees Degree Angle Drill Duraloc Depth Gauge Duraloc Drill Bit 3.8 Dia 10mm mm Drill Bit 25mm Duraloc Drill Bit 3.8 Dia 40mm mm Drill Bit 50mm Headed Drill PINNACLE 15mm Headed Drill PINNACLE 20mm Headed Drill PINNACLE 30mm Headed Drill PINNACLE 35mm Headed Drill PINNACLE 40mm Headed Drill PINNACLE 45mm Headed Drill PINNACLE 50mm HP Power PINNACLE Driver Augment Insert Tip Top Augment Insert Tip 90 Degree Rasping Power Adaptor Rasping Strike Plate Augment Rasping Handle Augment Adjustable Handles

33 GRIPTION TF Instruments Case Two: Finishing Rasp Case Catalog Code Description PINN AUGMENT FIN RASP 50X PINN AUGMENT FIN RASP 54X PINN AUGMENT FIN RASP 58X PINN AUGMENT FIN RASP 62X PINN AUGMENT FIN RASP 66X PINN AUGMENT FIN RASP 70X PINN AUGMENT FIN RASP 50X PINN AUGMENT FIN RASP 54X PINN AUGMENT FIN RASP 58X PINN AUGMENT FIN RASP 62X PINN AUGMENT FIN RASP 66X PINN AUGMENT FIN RASP 70X PINN AUGMENT FIN RASP 50X PINN AUGMENT FIN RASP 54X PINN AUGMENT FIN RASP 58X PINN AUGMENT FIN RASP 62X PINN AUGMENT FIN RASP 66X PINN AUGMENT FIN RASP 70X PINN AGUMENT FIN RASP 50X PINN AGUMENT FIN RASP 54X PINN AGUMENT FIN RASP 58X PINN AGUMENT FIN RASP 62X PINN AGUMENT FIN RASP 66X PINN AGUMENT FIN RASP 70X30 Case Three: Modular Rasp Case Catalog Code Description PINN AUGMENT MOD RASP 50/ PINN AUGMENT MOD RASP 54/ PINN AUGMENT MOD RASP 58/ PINN AUGMENT MOD RASP 62/ PINN AUGMENT MOD RASP 66/ PINN AUGMENT MOD RASP 70/72 33

34 GRIPTION TF Instruments Case Three: Modular Rasp Case Catalog Code Description HALF SHELL TRIAL 49mm HALF SHELL TRIAL 53mm HALF SHELL TRIAL 57mm HALF SHELL TRIAL 61mm HALF SHELL TRIAL 65mm HALF SHELL TRIAL 69mm PINN AUGMENT RASP +5mm OFFSET PINN AUGMENT RASP +10mm OFFSET PINN AUGMENT RASP +20mm OFFSET Buttress Screw Options: 6.5mm Cancellous Screws Catalog Code Description PINN CAN BONE SCREW 6.5mmX15mm PINN CAN BONE SCREW 6.5mmX20mm PINN CAN BONE SCREW 6.5mmX25mm PINN CAN BONE SCREW 6.5mmX30mm PINN CAN BONE SCREW 6.5mmX35mm PINN CAN BONE SCREW 6.5mmX40mm PINN CAN BONE SCREW 6.5mmX45mm PINN CAN BONE SCREW 6.5mmX50mm PINN CAN BONE SCREW 6.5mmX55mm PINN CAN BONE SCREW 6.5mmX60mm PINN CAN BONE SCREW 6.5mmX65mm PINN CAN BONE SCREW 6.5mmX70mm 34 Buttress Screw Options: 5.5mm PolyAxial Locking Screws Catalog Code Description mm POLYAXIAL SCREW FT 14mm mm POLYAXIAL SCREW FT 16mm mm POLYAXIAL SCREW FT 18mm mm POLYAXIAL SCREW FT 20mm mm POLYAXIAL SCREW FT 22mm mm POLYAXIAL SCREW FT 24mm mm POLYAXIAL SCREW FT 25mm mm POLYAXIAL SCREW FT 30mm

35 GRIPTION TF Instruments Augment Screw Options: 5.5mm PolyAxial Locking Screws Catalog Code Description mm POLYAXIAL SCREW FT 25mm mm POLYAXIAL SCREW FT 30mm mm POLYAXIAL SCREW FT 35mm mm POLYAXIAL SCREW FT 40mm mm POLYAXIAL SCREW FT 45mm mm POLYAXIAL SCREW FT 50mm mm POLYAXIAL SCREW FT 55mm mm POLYAXIAL SCREW FT 60mm mm POLYAXIAL SCREW FT 65mm mm POLYAXIAL SCREW FT 70mm Augment Screw Options: 5.5mm PolyAxial Non-Locking Screws Catalog Code Description mm NONLOCK SCREW PT 40mm mm NONLOCK SCREW PT 45mm mm NONLOCK SCREW PT 50mm mm NONLOCK SCREW PT 55mm mm NONLOCK SCREW PT 60mm mm NONLOCK SCREW PT 65mm mm NONLOCK SCREW PT 70mm Augment Screw Options: 5.0mm Cancellous Screws Catalog Code Description mm DIA TPRD HD PER SCRW mm DIA TPRD HD PER SCRW mm DIA TPRD HD PER SCRW mm DIA TPRD HD PER SCRW mm DIA TPRD HD PER SCRW mm DIA TPRD HD PER SCRW mm DIA TPRD HD PER SCRW mm DIA TPRD HD PER SCRW mm DIA TPRD HD PER SCRW mm DIA TPRD HD PER SCRW 70

36 DePuy GRIPTION TF Acetabular Augment System Important This Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. INDICATIONS The DePuy GRIPTION TF Acetabular Augments, Buttresses and Shims are indicated for use with the PINNACLE Acetabular Cup System, the PINNACLE Bantam Acetabular Cup System and the PINNACLE Revision Acetabular Cup System for total hip replacement in the following conditions: severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous hip surgery; and certain cases of ankylosis. INTENDED USE The porous GRIPTION TF titanium acetabular Augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled Augment/acetabular cup construct is intended for cemented or cementless use. The porous GRIPTION TF titanium shim is affixed to the mating Buttress using bone cement. This porous GRIPTION TF titanium Buttress is affixed to the mating acetabular cup using bone cement. The assembled Buttress/acetabular cup construct is intended for cemented or cementless use. CONTRAINDICATIONS Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who is incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and/or 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. WARNINGS AND PRECAUTIONS Ceramic-coated femoral stem prostheses are indicated for uncemented press fit fixation. CAUTION: DO NOT USE BONE CEMENT FOR FIXATION OF A CERAMIC COATED PROSTHESIS. Components labeled for Cemented Use Only are to be implanted only with bone cement. The following conditions tend to adversely affect hip replacement implants: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, history of infections, severe deformities leading to impaired fixation or improper positioning, tumors of the supporting bone structures, allergic reactions to materials, tissue reactions, and disabilities of other joints. ADVERSE EVENTS The following are the most frequent adverse events after hip arthroplasty, change in position of the components, loosening of components, wear or fracture of components, dislocation, infection, peripheral neuropathies, tissue reaction. REFERENCES 1. DePuy Orthopaedics, Inc. Data on file. 2. Zhang Y, Ahn PB, Fitzpatrick DC, Heiner AD, Poggie RA, Brown TD. Interfacial frictional behavior: cancellous bone, cortical bone, and a novel porous tantalum biomaterial. J Musculoskel Res. 1999;3(4): Krygier JJ, Bobyn JD, Poggie RA, et al. Mechanical characterization of a new porous tantalum biomaterial for orthopaedic reconstruction. Proc SIROT (International Research Society of Orthopaedic Surgery and Traumatology). Sydney Australia, Paprosky, W.G., P.G. Perona and M.J. Lawrence. Acetabular Defect Classification and Surgical Reconstruction in Revision Arthroplasty: A 6-Year Follow-Up Evaluation. The Journal of Arthroplasty 9(1),1994: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN USA Tel: +1 (800) Fax: +1 (574) DePuy Orthopaedics, Inc All rights reserved