Proven 1-4, Safe Performance. Product overview

Transcription

1 Proven 1-4, Safe Performance Product overview

2 DePuy Polyethylene: proven 1-4, safe performance Polyethylene has been used as an orthopaedic bearing material for more than 4 years. Over this period of time various advances have been made both in terms of raw material and processes, with the goal to deliver a better performing product. DePuy has pioneered many of these advances, delivering innovations and obtaining outstanding results in terms of clinical success. MARATHON, the first cross-linked polyethylene to be developed in hips, has set the benchmark for a new class of bearings, obtaining 9% in vivo reduction of wear at a mean follow-up of.7 years 1 and becoming a standard of care in cross-linked polyethylene. is an evolution in terms of raw material and manufacturing process, maintaining the clinical heritage and the foundation of MARATHON. With high wear resistance, mechanical integrity and safety thickness, along with oxidative stability obtained with a proven technology, DePuy polyethylene offers proven and safe performance for demanding patients. 1-4 DePuy polyethylene liners are designed to work with the PINNACLE Acetabular Cup System, providing a range of acetabular cup options, biological and mechanical fixation alternatives and advanced bearing technologies to provide surgeons the power to choose the precise combination that best meets the individual needs of each patient. PINNACLE Hip Solutions were developed with a team of key opinion leaders from across US and Europe. They utilised the proven POROCOAT Porous Coating fixation and combined it with engineering advances such as the patented Variable Interface Prosthesis (VIP) taper technology. This allows for the support of optimum performance metal and cross-linked polyethylene liners without compromising cup/insert congruency. Over 4, implanted 99.9 percent survivorship at years 6 3

3 A Solid Foundation was built on the proven 1 clinical heritage of MARATHON cross-linked polyethylene. Introduced in 1998, MARATHON was the first FDA-cleared cross-linked polyethylene in orthopaedics. Through the exclusive ALTRA-LINK material enhancement process, polyethylene was optimised to balance wear reduction and mechanical integrity while eliminating oxidation. 2,7 Wear Resistance To address a growing trend toward high demand patients, polyethylene liners were developed to reduce wear by 92 percent versus standard polyethylene and 1 percent versus MARATHON polyethylene liners using 28mm heads. 2,7 Volumetric Wear (mm3/m cycles) % Wear Reduction Metal on Standard Polyethylene Metal on Volumetric Wear (mm3/m cycles) % Wear Reduction Metal on MARATHON Metal on Optimised Wear Resistance 1-4,6,7 Optimised Wear Resistance 1-4,6,7 4

4 Mechanical Integrity is manufactured using a base resin bar stock of GUR 12 and then moderately cross-linked at 7. megarads, resulting in a material that maximises wear resistance while optimising mechanical integrity. 7 Compared with a 3X-annealed polyethylene, material has superior toughness, reducing the risk of failures due to impingement or rim loading. 3,7 Toughness (kj/m 2 ) % Greater Toughness 3X-Annealed Polyethylene Toughness (kj/m 2 ) % Greater Toughness Oxidative Resistance 1,7 And, because is moderately cross-linked at 7. megarads, the risk of cracking or fractures is reduced compared with a highly cross-linked material Mrad 7. Mrad Effect of Irradiation Dose on Toughness 3,7 Oxidative Stability material is remelted in an argon convection to consistently eliminate free radicals and oxidative potential. Annealed polyethylenes do not eliminate oxidation. 3,7,8 Oxidative Potential X Weeks of accelerated aging Enhanced Mechanical Toughness 3,7

5 High Stability, Low Wear To enhance stability, liners are available up to 36mm inner-diameter (ID) and now LD in 4, 44 and 48mm ID. liners are available in neutral, lateralised, face changing, and lipped designs. With a focus on wear reduction, liners are potentially less susceptible to higher wear as a function of head size. 7 A Solution For High Demand Patients BIOLOX delta ceramic heads on polyethylene liners provide a low-wear bearing for younger, high demand patients. This bearing combination produces 33 percent less volumetric wear than metal on, while resisting scratches and wear from third body debris such as bone fragments or cement. 4,7 Volumetric Wear (mg/million cycles) % Wear Reduction Metal on BIOLOX delta on Volumetric Wear (mg/million cycles) % Wear Reduction Metal on BIOLOX delta on High Performance Option 7 Volumetric wear with 36mm heads Scratch Resistance 4,7 Above chart compares volumetric wear after heads were roughened to emulate scratching from 3rd body debris 6

6 Enhanced Hip Stability* Optimised Range of Motion Maximised Head-to-Shell Ratio Femoral Heads S-ROM M Heads 11/13 Articul/eze M Heads 12/ mm 44 mm 48 mm N/A mm 44 mm 48 mm 4 mm Biolox delta TS 12/ mm LD liners provide increased hip stability and range of motion while maintaining low wear. 7 * When LD liners are used with DePuy stems that feature reduced neck geometry, surgeons are able to provide patients with a low wear hip, designed for stability and high function. 7 Enhanced Hip Stability LD liners enhance stability by incorporating larger inner diameters and a cylindrical buildup ( Charnley bore ) to increase subluxation jump distance. 7 * Optimised Range of Motion By combining larger inner diameters and optimised head-to-neck ratios, LD liners maximise available range of motion. 7 * Maximised Head-to-Shell Ratio LD liners are available with 4, 44 and 48 mm inner diameters starting in 6 mm outer diameter shells. Head size is maximised without compromising liner integrity. 7 * Compared to 28 mm metal-on-polyethylene bearings 7

7 Product Codes - and LD Implants and Instruments Implants neutral 28x neutral 28x x x lipped 28x lipped 28x neutral 32x neutral 32x x x x x lipped 32x lipped 32x lipped 32x lipped 32x lipped 32x lipped 32x lipped 32x lipped 32x neutral 36x neutral 36x neutral 36x neutral 36x neutral 36x neutral 36x neutral 36x neutral 36x x x x x x x x x x x x x x x x x LD x LD x LD x LD +4 4x LD +4 4x LD +4 4x LD x LD x LD x LD x LD +4 44x LD +4 44x LD +4 44x LD +4 44x LD x LD x LD x LD x LD +4 48x LD +4 48x LD +4 48x LD +4 48x76 Instruments Neutral 32x48 trial Neutral 32x trial Neutral 36x2 trial Neutral 36x4 trial x68 trial x68 trial x7 trial x72 trial x74 trial x76 trial x7 trial x72 trial x74 trial x76 trial 8

8 References 1. Anderson Engh, C., et al. A Randomized Prospective Evaluation of Outcomes After Total Hip Arthroplasty Using Cross-linked Marathon and Non cross-linked Enduron Polyethylene Liners. The Journal of Arthroplasty Vol. 21, No. 6 Suppl. 2, 26: Liao, Y.-S., K. Greer, et al. Effects of Resin and Dose on Wear and Mechanical Properties of Cross-linked Thermally Stabilized UHMWPE. Society for Biomaterials, the 7th World Biomaterials Congress, Sydney, Australia, K. Greer and M. Sharp. Comparison of crosslinked UHMWPE stabilized by sequential annealing or by remelting. Orthopaedic Research Society 3rd Annual Meeting, Transactions Vol.32, Poster #1784, San Diego, CA, Y.-S. Liao, K. Greer, A. Alberts. Effect of Head Material and Roughness on the Wear of 7. Mrad Crosslinked-Remelted UHMWPE Acetabular Inserts. Orthopaedic Research Society 4th Annual Meeting, San Francisco, CA, 28.. Sales data on file at DePuy Orthopaedics, Inc. 6. Kindsfater, K., W.P. Barrett, J.E. Dowd, C.B. Southworth and M.J. Cassell. 99.9% Midterm Survival of the Pinnacle Multi-Liner Acetabular Cup in a Prospective Multi-Center Study. Poster Presentation #P77, AAOS, San Diego, CA. February14-18, Data on file at DePuy Orthopaedics, Inc. Report number WR89, 24 and WR774, K. K. Wannomae, S. Bhattacharyya, A. Freiberg, D. Estok, W. H. Harris, and O. Muratoglu. In Vivo Oxidation of Retrieved Cross-linked Ultra High-Molecular-Weight Polyethylene Acetabular Components with Residual Free Radicals. The Journal of Arthroplasty Vol. 21 No 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. 7 Orthopaedic Drive Warsaw, IN USA Tel: +1 (8) Fax: +1 (74) DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel: +44 () Fax: +44 () DePuy International Ltd. and DePuy Orthopaedics, Inc All rights reserved Version 1 Issued: 9/11