Design Rationale and Surgical Technique

Transcription

1 Design Rationale and Surgical Technique 1

2 Contents GRIPTION TF Augments System Overview 3 Advanced Materials 4 Advanced Fixation 5 Advanced Instrumentation 7 Advanced Modularity 9 Possible Surgical Solutions 11 Surgical Technique Pre-operative Planning and Templating 13 Acetabular Preparation Finishing Rasp Technique 14 Acetabular Preparation Modular Rasp Technique 15 Implant Insertion Augment-First Technique 17 Implant Insertion Acetabular Shell-First Technique 19 Ordering Information 21 1

3 Filling the gap in acetabular revision surgery Advanced Materials Advanced Instrumentation Advanced Fixation 2

4 GRIPTION TF Augments System Overview 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. The GRIPTION TF Augments are designed to act as a defect filling implant in the case of severe bone loss in the acetabulum. The large surface area and congruent match to the PINNACLE cup promotes maximum bone loading and stability. Advanced geometry provides increased surface area for bone contact. Directional screw holes engineered to maximise fixation capability. To be used with 5.0 mm non-locking or 5.5 mm locking screws only Pin holes enhance visualisation & assessment of Augment fit and suitability. Can also be used as screw holes in augments 15mm in diameter and above Tight radius inner diameter on Augment to achieve precise fit with cup. Screwhole cutaways to optimise fit with PINNACLE Cup System. Proprietary TRUEBOND locking slot to help mechanically secure Augment to acetabular shell. To be used with 6.5mm PINNACLE bone screws only 3

5 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 an impressive initial scratch fit. Advanced Materials Advanced Instrumentation Advanced Fixation Coefficient of Friction Bone-like Modulus of Elasticity Compressive Yield Strength GPa MPa GRIPTION TF Augments 1 Zimmer Augments 2 0 GRIPTION TF 1 Trabecular Metal 4 Cortical 6 Bone Cancellous 7 Bone 0 GRIPTION TF 1 Trabecular Metal 3 4

6 Advanced Fixation Locking Screw Option GRIPTION TF implants have the ability to use locking screws to fixate the Augment to host bone. Locking screws help prevent the screw from becoming loose and backing out of the Augment. This minimises the risk of compromising the fixation as a result of screw migration. In addition, GRIPTION TF enables surgeons to implant diverging locking screws for even stronger fixation to the host bone. Advanced Materials Advanced Instrumentation Advanced Fixation 5

7 Cement, Cementless or Hybrid Fixation Options Prior to the availability of the GRIPTION TF Augments, the recognised method of securing 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 The TRUEBOND Cementless Technology and Hybrid fixation is achieved by using a short 6.5mm screw through the cup into the augment. Hybrid Fixation Cemented 6

8 Advanced Instrumentation The DePuy GRIPTION TF Revision System provides specialised instruments to prepare a customised bone envelope for the GRIPTION TF implants. The GRIPTION TF Revision System allows surgeons to select from 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 component of your technique. Advanced Materials Advanced Instrumentation Advanced Fixation 7

9 Finishing rasp Modular rasp 8

10 Advanced Modularity The DePuy GRIPTION TF Augments are compatible with the PINNACLE Hip Solutions Acetabular system. The PINNACLE Hip Solutions provide the largest selection of advanced bearing technologies, biological and mechanical fixation alternatives. With more implant designs and choices than any competitive system, you won t have to compromise when meeting the individual needs of patients. Bantam mm 100 series mm Sector mm Multi-Hole mm Revision mm Revision Deep Profile mm 9

11 Key Bone Stock and Landmark Considerations Radiographic landmarks are 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 Anatomical 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 10

12 Possible Surgical Solutions by Defect Classification The Paprosky Classification is the most widely used acetabular defect classification. 5 Type 1 Anterior/posterior columns are intact and supportive Greater than 70 percent of host bone to hemispherical shell contact Solution PINNACLE GRIPTION Cup Type 2A Anterior/posterior columns are intact and supportive Superior migration less than 2 cm Up to 30 percent of the cup may be uncovered superiorly Solution PINNACLE GRIPTION Multi-hole / Revision cup Type 2B Superior migration less than 2 cm Anterior/posterior columns are supportive Greater than 50 percent of host bone to hemispherical shell contact Solution PINNACLE GRIPTION Multi-hole / Revision cup Potential GRIPTION TF Augment Type 2C Rim is intact but distorted Medial wall defect and superior head centre migration (<2 cm) Teardrop is obliterated Solution PINNACLE GRIPTION Multi-hole / Revision cup Potential GRIPTION TF Augment 11

13 Type 3A percent of rim unsupportive Greater than 2 cm superior migration Less than 50 percent of host bone to hemispherical shell contact Solution PINNACLE GRIPTION Multi-hole / Revision cup GRIPTION TF Augment / Buttress Type 3B Greater than 60 percent of rim unsupportive Significant lysis and loss of posterior column bone stock Risk of pelvic discontinuity Solution PINNACLE GRIPTION Multi-hole / Revision cup GRIPTION TF Augment / Buttress Protrusio Cage 12

14 Surgical Technique Pre-operative Planning and Templating 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. 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 (>66 mm diameter), deep profile cups, or acetabular Augments. 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 centre 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 13

15 Acetabular Preparation Finishing Rasp Technique Once the acetabular cavity has been prepared, place the hemispherical acetabular trial into the prepared bed at the correct centre of rotation. Assess the defect, it is often helpful to use the matching size acetabular reamer or burr to first shape the defect to allow better positioning and movement of the rasp. Tip: For improved stability when rasping use adjustable handle ( ). Further stability may be achieved by using screws / headed drill pins in the trial shell. 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. For power rasping, the finishing rasp is attached to the rasping handle ( ) which is connected to the rasping power adapter ( ). Connection is confirmed by an audible click of button. The power adapter is designed only for the Stryker system 6 reciprocating saw. Alternatively the rasp can be used manually with the strike plate and mallet blows. 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 utilising a GRIPTION TF Buttress to span the defect. Tip: Use the headed drill pins to stabilise the Augments for trial reduction. 14

16 Acetabular Preparation Modular Rasp Technique Once the acetabular cavity has been prepared, utilise the half shell trial that is undersized by 1 mm from the last reamer or acetabular trial that was used. Place the trial in the prepared acetabular cavity at the correct centre of rotation. Attach the corresponding 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 utilising 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 obtained 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 utilising a GRIPTION TF Buttress to span the defect. Once appropriate stability has been obtained for the Augment trial, the definitive Augment is ready to be placed. 15

17 Free Hand Technique Once the acetabular cavity has been prepared, a hand held burr or acetabular reamer corresponding to the trialled cup size can be utilised 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 using the trial to avoid unnecessary bone removal. There is the option to use the finishing rasp in conjunction with the strike plate ( ) to manually finish the augment shape to promote a more accurate fit of the augment into the prepared bone envelope. 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 followed by the shell. In addition, at the time of insertion of the shell and Augment, the surgeon should decide whether cement fixation or mechanical fixation using a 6.5 mm bone screw will be utilised 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 TRUEBOND fixation slot in the Augment if mechanically mating. Use an ARD whose centre aligns with the centre of a screw hole. May be helpful to mark this ARD with a blue pen. Align the ARD with the centre line of the augment while impacting the shell, and the slot will line up with the screw hole. Have the surgeon mark a line on the center of the augment with a blue pen representing the centre of the slot. 16

18 Implant Insertion 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 superior face of the Augment to provide provisional fixation. Screw fixation utilising either 5.5 mm locking or 5.0 mm non-locking screws can now be performed. It is recommended, if host bone allows, to start with the inner two superior holes first. The outer holes can be used for screws in size 15mm augments and above. In size 10mm augments the outer holes are only for threaded pin fixation. If desired, supplemental fixation utilising the inside diameter holes of the Augment may now be used. Note : When utilising the inner diameter fixation holes, special care should be taken to ensure that the screw heads are fully seated and flush or countersunk slightly. Note: The TRUEBOND slot is only for connecting a PINNACLE cup to an augment via a 6.5 mm bone screw. The slot must not be used to try and thread a 5.0 mm or 5.5 mm screw through the augment and into the acetabular bone. Tip: For pre-drilling the inner diameter screw, the angled 45-degree drill bit may be easier to use than a straight drill bit. 17

19 Implant Insertion 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 TRUEBOND slot of the Augment lines up with an appropriate dome hole in the acetabular shell. The shell should be impacted utilising 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. A 6.5 mm screws should be placed through the appropriate dome hole in the shell and through the TRUEBOND 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: For pre-drilling the inner diameter screw, the angled 45-degree drill bit may be easier to use than a straight drill bit. 18

20 Implant Insertion Acetabular Shell-First Technique After preparation of the acetabulum and accompanying defect has been completed, insert the acetabular shell in accordance with the PINNACLE Acetabular Cup system technique. Screws for supplemental fixation of the PINNACLE cup should 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-tightened. 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 centre holes. The Augment can then be tapped into place behind the acetabular shell and into the prepared defect. Note: Acetabular shells should be placed at 45 degrees of abduction and 15 degrees of anteversion. Tip: Use the 3.8 mm drill bit for the 6.5 mm cancellous screws. Use the 3.8 mm drill bit for the 5.5 mm locking screw. If using 5.0 mm screw, use the 3.2 mm drill bit which is utilised with the PINNACLE Revision System. 19

21 Implant Insertion Acetabular Shell-First Technique, continued Screw fixation of the Augment is performed using 5.5mm locking or 5.0 non locking screws. The knurled, threaded pins can be used to help stabilise the Augment during screw insertion if necessary. Tip: The surgical assistant can stabilise the Augment with the inserter tip until provisional screw fixation is obtained. If mechanical mating of the shell and Augment is desired, then once the shell and Augment are in place, a standard PINNACLE 6.5 mm screw can be placed through the shell and the TRUEBOND 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 6.5 mm cancellous screws. Use the 3.8 drill bit for the 5.5 mm locking screw. If using 5.0 screw, use the 3.2 drill bit which is utilised with the PINNACLE Revision System. 20

22 Ordering information GRIPTION TF Augments Cat. No. 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 21

23 Ordering information GRIPTION TF Instruments Case One: Trial Case Cat. No. Description mm LOCKING SCREW CADDY (optional) Cat. No. 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 22

24 Ordering information GRIPTION TF Instruments Case Two: Finishing Rasp Case Cat. No. Description Degree Angle Drill DURALOC Depth Gauge DURALOC Drill Bit 3.8 Dia 10 mm mm Drill Bit 25 mm DURALOC Drill Bit 3.8 Dia 40 mm mm Drill Bit 50 mm Headed Drill PINNACLE 15 mm Headed Drill PINNACLE 20 mm Headed Drill PINNACLE 30 mm Headed Drill PINNACLE 35 mm Headed Drill PINNACLE 40 mm Headed Drill PINNACLE 45 mm Headed Drill PINNACLE 50 mm HP Power PINNACLE Driver Augment Insert Tip Top Augment Insert Tip 90 Degree Rasping Power Adaptor (Stryker Series 6 Reciprocating saw) Rasping Strike Plate Augment Rasping Handle Augment Adjustable Handle Cat. No. 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 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 70X30 Instruments Case Three: Modular Rasp Case (optional, instruments on request) Cat. No. 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/ HALF SHELL TRIAL 49 mm HALF SHELL TRIAL 53 mm HALF SHELL TRIAL 57 mm HALF SHELL TRIAL 61 mm HALF SHELL TRIAL 65 mm HALF SHELL TRIAL 69 mm PINN AUGMENT RASP +5 mm OFFSET PINN AUGMENT RASP +10 mm OFFSET PINN AUGMENT RASP +20 mm OFFSET 23

25 Ordering information GRIPTION TF Augment Screw Options (Non-sterile): 5.5 mm PolyAxial Locking Screws Cat. No. Description mm POLYAXIAL SCREW FT 25 mm mm POLYAXIAL SCREW FT 30 mm mm POLYAXIAL SCREW FT 35 mm mm POLYAXIAL SCREW FT 40 mm mm POLYAXIAL SCREW FT 45 mm mm POLYAXIAL SCREW FT 50 mm mm POLYAXIAL SCREW FT 55 mm mm POLYAXIAL SCREW FT 60 mm mm POLYAXIAL SCREW FT 65 mm mm POLYAXIAL SCREW FT 70 mm Augment Screw Options: 5.0 mm Cancellous Screws Cat. No. 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 65 PINNACLE Cup: 6.5 mm Cancellous Screws Sterile Locking screws: 5.5 mm PolyAxial Locking Screws Cat. No. Description mm POLYAXIAL SCREW FT 25 mm mm POLYAXIAL SCREW FT 30 mm mm POLYAXIAL SCREW FT 35 mm mm POLYAXIAL SCREW FT 40 mm mm POLYAXIAL SCREW FT 45 mm mm POLYAXIAL SCREW FT 50 mm mm POLYAXIAL SCREW FT 55 mm mm POLYAXIAL SCREW FT 60 mm mm POLYAXIAL SCREW FT 65 mm mm POLYAXIAL SCREW FT 70 mm Cat. No. Description PINN CAN BONE SCREW 6.5 mm X15 mm PINN CAN BONE SCREW 6.5 mm X20 mm PINN CAN BONE SCREW 6.5 mm X25 mm PINN CAN BONE SCREW 6.5 mm X30 mm PINN CAN BONE SCREW 6.5 mm X35 mm PINN CAN BONE SCREW 6.5 mm X40 mm PINN CAN BONE SCREW 6.5 mm X45 mm PINN CAN BONE SCREW 6.5 mm X50 mm PINN CAN BONE SCREW 6.5 mm X55 mm PINN CAN BONE SCREW 6.5 mm X60 mm PINN CAN BONE SCREW 6.5 mm X65 mm PINN CAN BONE SCREW 6.5 mm X70 mm 24

26 Notes 25

27 Notes 26

28 REFERENCES 1. DePuy Orthopaedics, Inc. Data on file. WR and WR 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): Zardiackas LD, Parsell DE, Dillon LD, Mitchell DW, Nunnery LA, Poggie R., Structure, metallurgy, and mechanical properties of a porous tantalum foam, J Biomed Mater Res. 2001; 58(2): Zimmer Inc. Trabecular Metal Technology. Available from: [Accessed Dec 2011] 5. Paprosky WG, Perona PG and Lawrence MJ. Acetabular Defect Classification and Surgical Reconstruction in Revision Arthroplasty: A 6-Year Follow-Up Evaluation. J.Arthroplasty 1994; 9(1): Reilly DT, Burstein AH, Frankel VH, The elastic modulus for bone, J. Biomechanics. 1974; (7): Li B, Aspden RM, Mechanical and material properties of the subchondral bone plate from the femoral head of patients with osteoarthritis or osteoporosis Ann Rheum Dis. 1997; (56): The third party trademarks used herein are the trademarks of their respective owners. This publication is not intended for distribution in the USA. DePuy Orthopaedics EMEA is a trading division of DePuy International Limited. Registered Office: St. Anthony s Road, Leeds LS11 8DT, England Registered in England No DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN USA Tel: +1 (800) Fax: +1 (574) DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel: +44 (0) Fax: +44 (0) DePuy International Ltd. and DePuy Orthopaedics, Inc All rights reserved version 1 Issued: 01/13 CA#DPEM/ORT/1212/0411