Product Rationale. Where Strength and Modularity Connect

Transcription

1 Product Rationale Where Strength and Modularity Connect

2 2 ReClaim Modular Revision Hip System Advanced Strength 1 Advanced Strength Over 600 million cycles of testing 1 Advanced Fixation Advanced Instrumentation Advanced Fixation Wagner Style 2.5º Taper Advanced Instrumentation Reduced Back-Table Footprint 2 and Opportunity for Increased OR Efficiency System Overview Distal Stem in 16 Diameters and 4 Lengths with Angled Option 2.5 Taper Anti-Subsidence Geometry

3 Where Strength and Modularity Connect 1 2 Offset Options Proximal Body in 3 Diameters and 4 Lengths Variable 360 Proximal Positioning Locking Bolt for Supplemental Fixation Grit-Blast Surface allows for Bony Apposition 5

4 RECLAIM Mod Possible Surgical Solutions by Defect Classification 2 The Paprosky Classification is the most widely used defect classification 3. All femoral stems listed can be used for any defect classification and may be appropriate for the situations shown below. Type 1 Minor cancellous bone loss exists anterior/posterior; the metaphysis is intact. Type 2 Cancellous/cortical structural bone is absent; the metaphysis is not intact. The diaphysis has minimal damage. S-Rom Modular Hip System Corail Revision Solution System

5 The RECLAIM Modular Revision Hip System combines advances in strength, fixation, and instrumentation to optimise both the surgical and clinical experience during moderate to complex hip revision surgery. 3 Type 3A The diaphysis is nonsupportive due to bone loss. Distal fixation over 4 cm can be achieved near the isthmus. Type 3B The diaphysis is not intact due to severe bone loss. Distal fixation over 4 cm can be achieved at the isthmus. Type 4 The cortices in the isthmus have been eroded. Alternative femoral fixation methods must be considered. REEF ular Revision Hip System LPS (Limb Preservation System)

6 Advanced Strength Over 600 million cycles of fatigue testing has demonstrated a superior construct strength profile 1 4 Robust Counter Bore 1 High Strength Neck 1 Proven Lateral Wall Thickness 1 Precision- Designed Undercut Low Stress Internal Threads 1 Fortified Taper 4 Optimised Taper Transition 1 Compression-Treated Barrel RECLAIM Modular Revision Hip System was mechanically tested to specifically verify the strength at each of these locations. Proven Splines 1

7 Proprietary Low Plasticity Burnishing (LPB ) process halts the propagation of cracks and increases the fretting fatigue resistance of the implant by applying residual compression to the Distal Stem taper. 4 5 Reproducible 907 kg (2,000 lb) Assembly Load for optimum and consistent Locking Taper performance coupled with a fortified design to provide a 50% increase in fatigue strength. 1 Locking Bolt Assembly for supplemental taper fixation

8 Advanced Fixation Built for stability to provide surgeons with confidence in restoring patients function Bi-Planar Taper Wagner style Distal Stem design engineered for maximum fixation, torsional stability, and resistance to subsidence. 5

9 Maximum Mechanical Stability Afforded by Grit-Blast surface treatment that also provides opportunity for bony apposition. 5 7 Maximum Axial and Torsional Stability Plateau spline design to engage multiple bony contact points to resist torque and subsidence.

10 Advanced Instrumentation Designed for optimal speed and efficiency. 8

11 Patent-Pending Versatility The ability to trial off the reamer allows validation of implant sizing and 360º of version Ream 2. Trial 3. Implant

12 The RECLAIM Modular Revision Hip System Size Offerings 10 Distal Stem Size Options Proximal Body Size Options Stem Lengths (B) Straight Stem Diameters (1 mm Increments) (A) 3º Angled Stem Diameters (1 mm Increments) (A) Heights (C) 135º Neck Angle 12/14 Articul/eze Mini Taper 20 mm 24 mm 28 mm Diameter (D) Diameter (D) Diameter (D) 14.5 mm Proximal body seating height 140 mm 14 mm - 21 mm N/A 190 mm 14 mm - 21 mm 240 mm N/A 290 mm N/A 14 mm - 27 mm 29 mm, 31 mm 16 mm - 27 mm 29 mm, 31 mm 18 mm - 21 mm 23 mm, 25 mm, 27 mm, 29 mm, 31 mm 75 mm Blue 85 mm Green 95 mm Yellow 105 mm Red 40 mm Offset (E) 45 mm Offset (E) 45 mm Offset (E) A E B D C

13 DePuy Revision Solutions: Managing the Unexpected DePuy Orthopaedics offers a vast array of femoral and acetabular revision products for addressing the unknowns of revision surgery. 11

14 The RECLAIM Modular Revision Hip System is designed to work seamlessly with DePuy s clinically proven 6,7 portfolio of acetabular solutions. 12

15 PINNACLE Hip Solutions provide the largest selection of advanced bearing technologies, biological and mechanical fixation alternatives while the GRIPTION TF Revision Augments, Buttresses, and Shims provide advancements in fixation, material and instrumentation. RECLAIM Modular Revision Hip System combined with the PINNACLE Hip Solutions and GRIPTION TF Revision Augments provides a strong platform for treating moderate to severe revision hip defects. 13

16 References 1. Data on file, DePuy Orthopaedics, Inc. (WR040038, WR , WR100206, DVA ) 2. Versus standard instrument kits. 3. Della Velle, C J, Paprosky, W G. Classification and an Algorithmic Approach to the Reconstruction of Femoral Deficiency in Revision Total Hip Arthroplasty. J Bone Joint Surg Am. 2003; 85: Hornbach, D, Prevey, P, Loftus, E. Application of low plasticity burnishing (LPB) to improve the fatigue performance of Ti-6Al-4V femoral hip stems. Symposium on Fatigue & Fracture of Medical Metallic Materials & Devices (LT Paper 263). Dallas, TX, Nov. 10, Berry DJ. Femoral Revision: distal fixation with fluted, tapered grit blasted stems. J Arthroplasty 2002; 17 (suppl 1): Kindsfater K, Barrett WP, Dowd JE, et al. 99.9% midterm survival of the pinnacle multi-liner acetabular cup in a prospective multi-center study. Poster #P077 presented at: AAOS Annual Meeting; February 14-18, 2007; San Diego. 7. National Joint Registry for England and Wales. 9th Annual Report Available from: Annualreports/tabid/86/Default.aspx Accessed December 6th 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 Ireland Loughbeg Ringaskiddy County Cork Ireland Tel: Fax: DePuy International Ltd. and DePuy Orthopaedics, Inc All rights reserved version 1 Revised: 01/13 CA#DPEM/ORT/1212/0384