DURALOC A WORLD LEADING CEMENTLESS ACETABULAR CUP SYSTEM

Transcription

1 DURALOC ACETABULAR CUP SYSTEM A WORLD LEADING CEMENTLESS ACETABULAR CUP SYSTEM

2 DURALOC A WORLD LEADING CEMENTLESS ACETABULAR CUP A UNIQUE CONCEPT Introduced in 1990, the Duraloc Cup has become one of the world s most widely used cementless cup systems. The Duraloc Cup introduced a new standard of structural integrity to help address polyethylene failure and maximize polyethylene performance. The Duraloc is a dome loaded cup, which helps ensure maximum liner/shell congruency, a minimum polyethylene thickness of 6mm and a secure locking mechanism. These features, combined with Porocoat Porous Coating, help enhance the long-term fixation of the shell. To these advances in design and materials, the Duraloc Cup also brings a wide array of initial fixation options and a surgical technique that helps ensure reproducible results. Today, the Duraloc Cup is the only second generation cup with more than 8 years of clinical usage and six year reported follow-up. 1 BIOLOGICAL FIXATION - A UNIQUELY STRONG INTERLOCK A proven platform for long-term fixation Porocoat Porous Coating on the Duraloc Cup s outer shell is an effective platform for long-term biological fixation. Its clinical performance has been tracked for more than 20 years, and retrieval studies consistently produce clear evidence of extensive ingrowth. 2 Long-term histological evidence demonstrates convincingly that Porocoat Porous Coating is successful in achieving initial stability and extensive ingrowth. 3,4 Clinically validated Recent clinical studies 1,5 have confirmed the validity of the high-congruency design principles and demonstrated the efficacy of the dome-loading design of the Duraloc Cup. This design reduces contact stress and helps minimize the potential for polyethylene fatigue. 6 The Duraloc Cup has an unrivaled history of success. Worldwide, the Duraloc Cup has won acceptance from surgeons for both cementless and hybrid hip replacements. The Duraloc Acetabular Cup System The polyethylene liner of the Duraloc Cup is fully supported over the dome area by the metal shell. Maximized Polyethylene Thickness Porocoat Porous Coating Congruency Locking Mechanism Porocoat proud Porous Coating allows shell fixation at the acetabular opening.

3 The unique Porocoat outer surface of the cup provides an excellent, proven surface for extensive ingrowth. Histological studies show 99 percent ingrowth with Porocoat Porous Coating, producing a dense interlock. 7 Average pore size (microns) Optimum pore size LARGE BEADS II LARGE BEADS CANCELLOUS STRUCTURE FIBER MESH Immediate stability The high coefficient of friction of Porocoat Porous Coating, 33 percent higher than its closest equivalent, 9 enhances the scratch fit and improves the initial stability of the cup. Optimum porosity gradient The patented Porocoat surface provides an excellent, proven surface for ingrowth to help achieve long-term fixation. Porocoat is a sintering of metal beads to a metal substrate, creating a three-dimensional structure of inter-connecting pores into which tissue grows. Research has shown that the ingrowth process is affected by the pore size. Pores below 50 microns may restrict blood vessel development and hinder uniform maturation of tissue. In larger pores, 400 microns and above, ingrowth may be slow, inconsistent and tends to be fibrous. 9 Porocoat Porous Coating has an average pore size of 250 microns, which has been reported as the optimum size for rapid and complete ingrowth. 7 Additionally, the beads are arranged to produce higher porosity on the outer edge and lower porosity at the substrate. This porosity gradient helps optimize the volume and density of ingrowth. A pore size comparison of alternative coatings 8 Optimum average pore size is 250 microns. Smaller pores may restrict ingrowth development; larger pores may produce slower, inconsistent ingrowth. POROCOAT POROUS COATING During impaction, a scratch fit is achieved. As the cup is seated, autogenous bone particles may be grafted into the pores between the beads, which may potentially help in achieving secure biological fixation. A. Coefficient of friction B. Grafting Potential A B POROCOAT POROUS COATING CANCELLOUS STRUCTURE LARGE BEADS II FIBER MESH SMOOTH STEEL A - COEFFICIENT OF FRICTION The coefficient of friction and grafting potential of contemporary surface coatings. 9 B - GRAFTING POTENTIAL A high coefficient of friction helps give Porocoat Porous Coating a superior potential for ingrowth.

4 DURALOC A WORLD LEADING CEMENTLESS ACETABULAR CUP STRUCTURAL INTEGRITY - MANAGING LOAD TRANSFER TO MAXIMIZE PERFORMANCE Making congruency an industry standard The Duraloc Cup was designed to achieve total congruency between the polyethylene liner and the metal shell. Unlike first generation designs, loading from the femoral head is spread evenly across the load bearing area of the liner/shell interface, avoiding loads at the rim of the metal shell/polyethylene liner. The Duraloc shell is spherical and highly conforming to the polyethylene. As a result, efficient load transfer is achieved and contact stresses are substantially reduced. 11 There are no isolated stresses found around the rim, where excessive cyclic loading may produce cracks and failure of the polyethylene. The example below demonstrates a competitive second-generation cup which is a rim-loaded device. DURALOC Load Bearing Area Liner Shell COMPETITOR Shell Liner Non- Congruent Gap Contact Area The Duraloc shell/liner interface is highly congruent, ensuring efficient load transfer to minimize micromotion. 10 Locking Mechanism Area Shell Rim Gap Contact Area Rim loading cup designs limit load transfer to the dome area, allowing the liner to flex and distort within the shell. HIGH HIGH LOW No Rim Loading Finite element analysis demonstrates the Duraloc Cup to be the only cup that prevents rim loading, ensuring 100 percent dome loading. 11 LOW Rim Loading Extended pressure exerted around the inner rim of a shared rim and dome loading design increases micromotion at the shell/liner interface. 10

5 Optimum polyethylene thickness Polyethylene liner thickness has been shown to affect the performance of the acetabular cup. Thin liners (below 4mm) are reported to have contributed to failure through wear, fatigue fracture and osteolysis. 12,13,14,15,16 The Duraloc Cup has a minimum thickness of 6mm* (Figure 1) for the polyethylene liner (sizes 48-74mm), comfortably above the thicknesses at which some types of failures have been shown to occur. Duraloc Acetabular Cup Metal and Polyethylene Thickness Metal Duraloc Shell (Cup Thickness mm 26mm 28mm 32mm Size) (mm) ID ID ID ID *Except Duraloc Bantam Cups Secure liner location The patented Sensor-Ring locking mechanism in the metal shell secures the polyethylene liner (Figure 2). It conforms to dimensional variances with the polyethylene liner caused by creep deformation and helps eliminate the risk of liner dissociation. In addition, six anti-rotation devices (ARDs) located within the shell maintain liner/cup orientation, control rotation and allow the liner to be placed in any position (as required to achieve joint stability). Figure 1: A minimum 6mm thickness of polyethylene is maintained around the Duraloc Cup liner, ensuring material integrity and minimizing adverse contact stresses. Figure 2: Example of the Duraloc locking ring capturing the polyethylene liner. Sensor Ring ARD Figure 3: The Sensor-Ring mechanism and anti-rotation devices (ARDs) control rotation and micromotion. Figure 4: Example of Duraloc s inner diameter machine finish. A machined inner diameter The Duraloc Cup employs a machined inner diameter (Figure 4) to maximize the fit of the polyethylene liner to the inner surface of the metal shell. By avoiding a polished inner surface, the inner diameter form (roundness) is held to precise tolerances, thereby maximizing the congruency of the liner/shell interface. Given the minimal amount of micromotion in acetabular components 17 (pistoning and rotation), as compared to increased motion in fixed bearing knee components 18, polishing the inner surface of the acetabular shell has no apparent benefit. Helping to safeguard the performance of polyethylene through sterilization Polyethylene durability has improved as more stringent controls over manufacturing standards have been introduced. The structural consistency of Enduron Polyethylene exceeds the wide variation in material quality permitted by both ASTM F-648 and ISO In October 1995, DePuy introduced gas plasma sterilization to eliminate radiation sterilization induced oxidation. Gas plasma sterilization is a low temperature process that meets worldwide standards for effective sterilization. 19 It avoids the formation of free radicals and degradation of the polyethylene when exposed to oxygen or in vivo conditions. Gas plasma sterilization produces no toxic by-products and ensures product and process compatibility for safe and effective sterilization. Together, these two features work to help reduce micromotion at the liner/shell interface (Figure 3).

6 DURALOC A WORLD LEADING CEMENTLESS ACETABULAR CUP SHELL OPTIONS TO TREAT PRIMARY AND REVISION CASES Duraloc 100 Series Cup Titanium acetabular shell with Porocoat proud Porous Coating No screw-holes Available in sizes 48mm through 66mm Indicated for cementless biological fixation Duraloc 300 Series Cup Titanium acetabular shell with Porocoat proud Porous Coating Incorporates three porous-coated spikes to maximize implant stability and rotational control Available in sizes 48mm through 74mm (peripheral screw holes offered in sizes 68mm through 74mm for revision indications) Indicated for cementless biological fixation Duraloc 400 Series Cup Titanium acetabular shell with Porocoat proud Porous Coating Incorporates four peripheral fins to offer additional implant stability and rotational control (no screw holes) Available in sizes 48mm through 66mm Indicated for cementless biological fixation Duraloc 100 Series Cup Duraloc 300 Series Cup Duraloc 400 Series Cup Duraloc Sector Cup Duraloc 1200 Series Cup Duraloc Sector Cup Titanium acetabular shell with Porocoat proud Porous Coating Incorporates three screw holes in one quadrant to offer additional implant stability Available in sizes 48mm through 66mm Indicated for cementless biological fixation Duraloc 1200 Series Cup Titanium acetabular shell with Porocoat proud Porous Coating Incorporates eight to 12 screw holes, depending on cup size, to maximize implant stability and provide screw position flexibility Available in sizes 48mm through 74mm Indicated for cementless biological fixation Duraloc Bantam Series Cup Titanium acetabular shell with Porocoat proud Porous Coating 38mm through 46mm two-piece design Dome screw holes allow additional implant stability and surgical flexibility 10 degree lipped Enduron Liners available: mm in 38mm, 40mm, 42mm, 44mm and 46mm OD; 26mm in 44mm and 46mm OD; 28mm in 46mm OD only Indicated for cementless biological fixation Duraloc Bantam Cup NOTE: The Sector, 1200 Series and Bantam Cups use 6.5mm cancellous bone screws.

7 DURALOC CUP LINERS MAXIMIZE POLYETHYLENE OPTIONS AND ADDRESS IMPLANT STABILITY Duraloc Neutral Liner Provides 180 degree coverage of the femoral head Offers a symmetric face about the metal shell rim Typical range of motion (using 28mm +5 Articul/eze Head and Endurance Stem): 124 med/lat 124 ant/post Duraloc 20 Degree Face Changing/Hooded Liner Provides 180 degree coverage of the femoral head plus a 5mm build-up to address dislocation Depending on placement, offers 20 degrees of anteversion/retroversion and/or 20 degrees of abduction/adduction Typical range of motion: 107 med/lat 122 ant/post 5mm Build-up Duraloc 10 Degree Face Changing Liner Provides 180 degree coverage of the femoral head Depending upon placement, changes orientation (anteversion, retroversion, abduction, adduction) by 10 degrees Typical range of motion: 113 med/lat 113 ant/post Duraloc +4 Neutral Liner Provides 180 degree coverage of the femoral head Offers a symetrical face about the metal shell rim Lateralizes head center 4mm Typical range of motion: 124 med/lat 124 ant/post NOTE: Range of motion measurements taken using Endurance Stem with 28mm+5 Articul/eze Head DURALOC CUP 7-YEAR CASE HISTORY 64-year-old male presents with osteoarthritis. A 60mm Duraloc 300 Series Cup with a 32mm ID 10 liner and AML Stem were implanted. The joint remains stable with the Duraloc Cup exhibiting no signs of loosening or radiographic evidence of wear.

8 DURALOC SURGICAL TECHNIQUE PREOPERATIVE PLANNING TRIAL SIZING Acetabular Templating Each step of the Duraloc Cup surgical technique is designed to achieve fixation and ensure a biomechanically sound procedure. A biomechanically sound arthroplasty requires the acetabular center to be placed in a nearanatomic position. Use preoperative planners with standard full pelvic x-rays to visualize the ideal size and position of the prosthesis in both A/P and lateral views. Standardize exposures so x-rays will be comparable throughout the postoperative course. Multiple planner overlays offer ample choices for adequate sizing of the prosthesis to the individual patient. Patient Positioning and Preparation The Duraloc Acetabular Cup may be implanted using any of the standard approaches for total hip arthroplasty. The goal of any approach selected is adequate visualization of the entire rim and depth of the acetabulum. The following technique is a typical posterior lateral approach. Acetabular Reaming Place the patient in the lateral decubitus position with the affected hip up. Obtain sufficient patient stability prior to draping and prep. It is imperative that the pelvis remain stable, but that the operated leg be mobile. This position enables proper placement of the acetabular cup. Once proper exposure of the acetabulum is attained and any obstructing osteophytes are removed, acetabular preparation begins with a spherical reamer that fits easily within the acetabulum. Acetabular graters are available with outside diameters measuring from 36-74mm, progressing in 1mm increments. Prior to acetabular reaming, check the proper orientation of the reamers. A position of approximately 45 degrees of lateral inclination with approximately 10 to 30 degrees of anteversion is recommended. Remember that the pelvis may be held in a slightly flexed (15 to 20 degree) position by the lateral patient positioner. Continue reaming, using progressively larger reamers, and remove any remaining articular cartilage and a portion of the subchrondral plate to partially bleeding bone. Preserve as much of the subchondral plate as possible. Remove only avascular sclerotic bone. The horseshoe-shaped subchrondral plate need not be completely removed to the depth of the acetabular fossa, and reaming should never proceed medially past this inner table. If adequate bleeding bone cannot be obtained by reaming to the inner table, use a larger diameter reamer for more peripheral reaming without further medialization (Figure 5). In general, at least two-thirds of the subchrondral plate should present a healthy surface. Bleeding bone is most easily obtained posterior and superior toward the ilium. The anterior and posterior rims should be frequently palpated for strength and thickness during the reaming process. Figure 5 Figure 6 To achieve an optimal press-fit, under reaming of 1 to 2mm to the templated acetabular cup is required. Usually a cup of 54mm or smaller requires 1mm under reaming, while a 56mm or larger cup generally requires 2mm under reaming to obtain adequate stability. If the component does not appear to achieve adequate stability, adjunctive fixation may be required. Trial Sizing With the Duraloc System, a complete trial reduction can be performed prior to component implantation. This will ensure proper cup placement, inclination and anteversion. Screw the trial sizer (1 to 2mm larger in diameter than last reamer used) onto the end of the Duraloc Cup Impactor. The trial sizer is etched with actual size of the implant that is planned. Impact the trial sizer into the reamed acetabulum. The acetabular alignment guide allows placement of the acetabular component at 45 degrees of lateral inclination and zero, 10, 20 or 30 degrees of anteversion depending on the patient s anatomical requirements. The trial sizer will verify proper seating via its dome grooves. Assess coverage of the acetabular component (Figure 6). Unscrew the Duraloc impactor to allow placement of the trial liner. The rim fit of the fully seated trial shell should be tight enough to make it difficult to alter its position. The inferior rim of the trial shell should be level with the bottom of the teardrop, matching the templated position. Secure the appropriate size neutral, 10, 20, +4 trial liner to the hex head screwdriver and screw into the trial sizer shell (Figure 7). For example, a 56mm trial sizer will accommodate a 56mm trial liner. The surgeon can place the trial in any rotational position with the Duraloc trial liners. With the lipped

9 IMPACTION OF THE SHELL POLY LINER IMPLANTATION Lipped Liner Indentation Figure 7 Straight Impactor with Alignment Guide Figure 9 Note: Certain sizes of the Duraloc poly liners fit into two sizes of acetabular shells. The following depicts the overlap. trials, an electrocautery knife or methylene blue is used to mark the bone adjacent to the indention mark, which corresponds to the highest portion of the lip and assists in correct positioning of the actual implant. Note: When using the Duraloc Bantam Cup Trial Sizers (Cat. Nos /46-503), the Bantam Cup Adaptor (Cat. No ) must be used with the Duraloc straight or curved impactor. This adaptor will fit the dome screw hole of the Bantam Cup Trial Sizers. Acetabular Cup Implantation Figure 8 Screw the cup impactor into the appropriate size Duraloc shell. With the acetabulum clean and dry, use standard impaction techniques to insert the shell (Figure 8). Be sure to maintain proper inclination (45 degrees) and 20 to 30 degrees of anteversion during impaction. Unscrew the impactor once the shell is seated within the acetabulum. The apex dome hole in the shell will verify proper seating. The apex hole may be plugged using the positive stop Apex Hole Eliminator. Note: When impacting the Duraloc Bantam Shell (Cat. Nos /46-503), the Bantam Impactor Adaptor (Cat. No ) must be used with the Duraloc straight or curved impactor. This adaptor will fit the apex dome hole in the Bantam Cups. For additional iliac fixation, one or more 6.5mm cancellous screws may be inserted at Curved Impactor with Alignment Guide the surgeon s discretion for the 1200 Series, Sector Cup and Bantam Cup. Self-tapping cancellous screws are available in 12 lengths ranging from 15-70mm (5mm increments). Using a 3.2 or 3.8mm drill bit and drill guide, drill one or more pilot holes through the holes in the metal cup at the sites chosen for screw placement. Remove the drill and drill guide and use the depth gauge to estimate the appropriate screw length. Fully seat the screws using the hexhead screwdriver. The use of additional fixation screws requires experience. Care should be taken to not perforate the inner wall of the acetabulum with any sharp instrument to avoid injury to the neurvascular structures within the pelvis. Poly Liner Implantation Place the appropriate polyethylene liner into the metal shell in the predetermined position. In the case of a lipped poly liner, position the indention in the rim of the poly to correspond to the mark made on the bony rim of the acetabulum during trial reduction (Figure 9). This indention corresponds to the highest part of the lip. Impact the liner into the metal shell using the properly sized (22.225, 26, 28, or 32mm) polyethylene impactor. The liner will lock into the titanium shell as it is impacted. Note: If it is necessary to remove a poly liner, a new locking ring and poly liner will need to be used (see Locking Ring Installation). 56 or 68mm liner fits a 56 or 68mm shell 58 or 70mm liner fits a 58 or 70mm shell 60 or 72mm liner fits a 60 or 72mm shell 62 or 74mm liner fits a 62 or 74mm shell The polyethylene liners are labeled accordingly and the sizing overlap reduces the amount of polyethylene liner inventory necessary. Locking Ring Installation If it becomes necessary to remove a liner from an implanted Duraloc Cup, use the polyethylene extractor. Position the extractor teeth (all aligned) on the outer diameter, with the inner diameter jaw positioned against the poly liner, squeezing the handle. At this time, the liner will raise slightly. Begin turning the top of the extractor clockwise. The middle tooth will raise itself against the metal shell face, disassociating the poly from the shell. Due to damage to the locking ring as a result of the liner extraction, the locking ring and poly must both be replaced. Remove the locking ring by hooking it with a towel clamp or Kocher clamp, and work it free from the locking ring groove. To insert a new locking ring, start one end of the ring in the groove first, followed by each subsequent bend in the ring. The opposite end of the ring will snap into position. Make sure that the new locking ring is completely seated into the locking ring groove. Postoperative Management A standard postoperative care protocol should be followed. Specific details of the postoperative regimen should always be geared to fit the patient s individual and physical abilities.

10 DURALOC ORDERING INFORMATION DURALOC CUP Duraloc 100 Series 48mm Duraloc 100 Series 50mm Duraloc 100 Series 52mm Duraloc 100 Series 54mm Duraloc 100 Series 56mm Duraloc 100 Series 58mm Duraloc 100 Series 60mm Duraloc 100 Series 62mm Duraloc 100 Series 64mm Duraloc 100 Series 66mm Duraloc 300 Series 48mm Duraloc 300 Series 50mm Duraloc 300 Series 52mm Duraloc 300 Series 54mm Duraloc 300 Series 56mm Duraloc 300 Series 58mm Duraloc 300 Series 60mm Duraloc 300 Series 62mm Duraloc 300 Series 64mm Duraloc 300 Series 66mm Duraloc 300 Series 68mm Duraloc 300 Series 70mm Duraloc 300 Series 72mm Duraloc 300 Series 74mm Duraloc 400 Series 48mm Duraloc 400 Series 50mm Duraloc 400 Series 52mm Duraloc 400 Series 54mm Duraloc 400 Series 56mm Duraloc 400 Series 58mm Duraloc 400 Series 60mm Duraloc 400 Series 62mm Duraloc 400 Series 64mm Duraloc 400 Series 66mm Duraloc Sector 48mm Duraloc Sector 50mm Duraloc Sector 52mm Duraloc Sector 54mm Duraloc Sector 56mm Duraloc Sector 58mm Duraloc Sector 60mm Duraloc Sector 62mm Duraloc Sector 64mm Duraloc Sector 66mm Duraloc 1200 Series 48mm Duraloc 1200 Series 50mm Duraloc 1200 Series 52mm Duraloc 1200 Series 54mm Duraloc 1200 Series 56mm Duraloc 1200 Series 58mm Duraloc 1200 Series 60mm Duraloc 1200 Series 62mm Duraloc 1200 Series 64mm Duraloc 1200 Series 66mm Duraloc 1200 Series 68mm Duraloc 1200 Series 70mm Duraloc 1200 Series 72mm Duraloc 1200 Series 74mm Duraloc Bantam 38mm Duraloc Bantam 40mm Duraloc Bantam 42mm Duraloc Bantam 44mm Duraloc Bantam 46mm Duraloc Apex Hole Eliminator Positive Stop POLYETHYLENE CUP LINERS Enduron 10D x Enduron 10D x Enduron 10D x Enduron 10D x Enduron 10D x56 or Enduron 10D x58 or Enduron 10D x60 or Enduron 10D x62 or Enduron 10D x Enduron 10D x Enduron Neutral 26x Enduron Neutral 26x Enduron Neutral 26x Enduron Neutral 26x Enduron Neutral 26x56 or Enduron Neutral 26x58 or Enduron Neutral 26x60 or Enduron Neutral 26x62 or Enduron Neutral 26x Enduron Neutral 26x Enduron 10D 26x Enduron 10D 26x Enduron 10D 26x Enduron 10D 26x Enduron 10D 26x56 or Enduron 10D 26x58 or Enduron 10D 26x60 or Enduron 10D 26x62 or Enduron 10D 26x Enduron 10D 26x66

11 Enduron Neutral 28x Enduron Neutral 28x Enduron Neutral 28x Enduron Neutral 28x Enduron Neutral 28x56 or Enduron Neutral 28x58 or Enduron Neutral 28x60 or Enduron Neutral 28x62 or Enduron Neutral 28x Enduron Neutral 28x Enduron 10D 28x Enduron 10D 28x Enduron 10D 28x Enduron 10D 28x Enduron 10D 28x56 or Enduron 10D 28x58 or Enduron 10D 28x60 or Enduron 10D 28x62 or Enduron 10D 28x Enduron 10D 28x Enduron Neutral 32x Enduron Neutral 32x Enduron Neutral 32x56 or Enduron Neutral 32x58 or Enduron Neutral 32x60 or Enduron Neutral 32x62 or Enduron Neutral 32x Enduron Neutral 32x Enduron 10D 32x Enduron 10D 32x Enduron 10D 32x56 or Enduron 10D 32x58 or Enduron 10D 32x60 or Enduron 10D 32x62 or Enduron 10D 32x Enduron 10D 32x Enduron +4 Liner 28x Enduron +4 Liner 28x Enduron +4 Liner 28x Enduron +4 Liner 28x Enduron +4 Liner 28x56 or Enduron +4 Liner 28x58 or Enduron +4 Liner 28x60 or Enduron +4 Liner 28x62 or Enduron +4 Liner 28x Enduron +4 Liner 28x Enduron +4 Liner 32x Enduron +4 Liner 32x Enduron +4 Liner 32x56 or Enduron +4 Liner 32x58 or Enduron +4 Liner 32x60 or Enduron +4 Liner 32x62 or Enduron +4 Liner 32x Enduron +4 Liner 32x Enduron 20D 28x Enduron 20D 28x Enduron 20D 28x Enduron 20D 28x Enduron 20D 28x56 or Enduron 20D 28x58 or Enduron 20D 28x60 or Enduron 20D 28x62 or Enduron 20D 28x Enduron 20D 28x66 LOCKING RINGS Duraloc Bantam Locking Ring 38mm Duraloc Bantam Locking Ring 40mm Duraloc Bantam Locking Ring 42mm Duraloc Bantam Locking Ring 44mm Duraloc Bantam Locking Ring 46mm Duraloc Dynamic Locking Ring 48mm Duraloc Dynamic Locking Ring 50mm Duraloc Dynamic Locking Ring 52mm Duraloc Dynamic Locking Ring 54mm Duraloc Dynamic Locking Ring 56 or 68mm Duraloc Dynamic Locking Ring 58 or 70mm Duraloc Dynamic Locking Ring 60 or 72 mm Duraloc Dynamic Locking Ring 62 or 74mm Duraloc Dynamic Locking Ring 64mm Duraloc Dynamic Locking Ring 66mm CANCELLOUS BONE SCREWS mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw mm Cancellous Screw

12 References: 1. Kronick, J. and Paprosky, W.G.: Results of Cementless Acetabular Components: Minimum 6 Years Follow Up. Presented at Harvard Hip Course, Boston, Mass. October Engh, C.A.; Hooten, Jr. J.P. and Zettl-Schaffer, K.F. et al.: Evaluation of Bone Ingrowth with Proximally and Extensively Porous-Coated AML Prostheses Retrieved from Autopsy. Journal of Bone and Joint Surgery. 1995; 77: Pilliar, R.M.: Powder Metal-Made Orthopaedic Implants with Porous Surface for Fixation by Tissue Ingrowth. Clinical Orthopaedics and Related Research, 176, Engh, C.A. and Massin, P.: Cementless Total Hip Replacement Using the AML Stem: 0-10 Year Results Using a Survivorship Analysis. Clinical Orthopaedics and Related Research, 249, Paprosky, W.G.: Acetabular Fixation Options in the 1990s. Cementless Sockets: Optimums and Outcomes. Orthopaedics, 9(20): 777-9, Bartell, D.L.; Burstein, A.H.; Toda, M.D. and Edwards, D.L.: The Effect of Conformity and Plastic Thickness on Contact Stresses in Metal-Backed Plastic Implants. J Bio Eng. Vol 107, August Bobyn, J.D., et al.: The Optimum Pore Size for the Fixation of Porous Surfaced Metal Implants by the Ingrowth of Bone. Clinical Orthopaedics and Related Research, 150, Data on file, DePuy International Ltd. 9. Kelman, D.: Friction Analysis of Textured Coatings. Test Report 276, DePuy, Inc., Litsky, A.S. and Wasielewski, R.C.: Micromotion Between the Polyethylene Liner and the Acetabular Cup in Total Hip Prostheses. Orthopaedic BioMaterials Laboratory, Ohio State University, Columbus, Ohio, Tomaszewski, P.: Technical Memo, May 29, 1997, DePuy Orthopaedics. 12. Berry, D.J.; Barnes, C.L.; Scott, R.D.; Cabanela, M.E. and Poss, R.: Catastrophic Failure of the Polyethylene Liner of Uncemented Acetabular Components. Journal of Bone and Joint Surgery, 76-B, No 4, Collier, J.P.; Mayor, M.B.; Jensen, R.E.; Surprenant, V.A.; Surprenant, H.P.; McNamara, J.L. and Belec, L.: Mechanisms of Failure of Modular Prostheses. Clinical Orthopaedics and Related Research, 285, Astion, D.J.; Saluan, P.; Stulberg, B.N.; Rimnac, C.M. and Li, S.: The Porous-Coated Anatomic Total Hip Prosthesis: Failure of the Metal-Backed Acetabular Component. Journal of Bone and Joint Surgery, 77-A, No.5, Ries, M.D.; Collis, D.K. and Lynch, F.: Separation of the Polyethylene Liner from Acetabular Cup Metal Backing. Clinical Orthopaedics and Related Research, 282, Rosner, B.I.; Postak, P.D. and Greenwald, A.S.: Cup/Liner Incongruity of Two Piece Acetabular Designs: Implications in the Generation of Polyethylene Debris. Orthopaedic Research Laboratories, The Mt. Sinai Medical Center, Cleveland, Ohio, Seth, A.K. and Litsky, A.S.: Micromotion between the polyethylene and the acetabular cup in total hip prosthesis. 43rd Annual Meeting, Orthopaedic Research Society, February 9-13, 1997, San Francisco, California. 18. Parks, N.L., et al.: Modular tibial insert micromotion: A concern with contemporary knee implants. Coventry Award Paper, 1998 Knee Society, New Orleans, Louisiana. 19. Caputo, R.A.: AbTox Plazlyte Plasma Sterilisation. Journal of Healthcare Materials Management, 12, CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician. For more information about DePuy products, visit our web site at 2.5M (Rev.2) Printed in USA DePuy Orthopaedics, Inc. All rights reserved.