FDA APPROVES FIRST CERAMIC-ON-METAL IMPLANT
FOR HIP REPLACEMENT
WARSAW, IN – JUNE 16, 2011 – DePuy Orthopaedics, Inc., (DePuy) a global leader in devices for joint replacement, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s PINNACLE® CoMplete® Acetabular Hip System, the first ceramic-on-metal hip implant available in the United States.
"The CoMplete system offers durability and stability, along with enhanced low-wear characteristics, that will provide surgeons with an important new option for patients with severe osteoarthritis,” said Randy Kilburn, Vice President, U.S. Marketing, DePuy Orthopaedics, Inc. “This addition to the PINNACLE platform, when available, will provide surgeons with the freedom to choose the bearing combination, whether it is metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, or ceramic-on-metal, that best meets the patient’s individual needs.”
The PINNACLE® Cup has been available for more than 10 years, and has become one of the most widely used and clinically successful modular acetabular cup systems for hip replacement.1, 2 A multi-center clinical study conducted by leading orthopaedic surgeons showed that 96.1% of PINNACLE® Hips are still in use 8 years after surgery.3
The FDA approval of the CoMplete system was based in part on results from a two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing. As is typical for PMA approved devices, DePuy will commence a post-market study to monitor patients for short-, mid- and long-term safety and effectiveness.
The performance of a hip replacement depends on a patient’s age, weight, activity level and other factors. There are potential risks, and recovery takes time. The risks associated with the CoMplete system are similar to those of other hip replacement systems. Some of the most common risks after total hip replacement include change in position of the components, loosening of components, dislocation, infection or tissue reaction. Generally, patients should not undergo hip replacement procedures if they have an active infection that could spread to other areas of the body, are skeletally immature or have inadequate bone or muscle tissue that may not support the implant. People with conditions limiting rehabilitation should not have hip surgery. Patients should consult with an orthopaedic surgeon to determine if hip replacement surgery is appropriate for them.
About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. is a leading global provider of orthopaedic devices for hip, knee, extremities and trauma, as well as bone cement and operating room products. It is part of the DePuy Family of Companies of Johnson & Johnson, which have a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision – Never Stop Moving® –to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world.
1. National Joint Registry for England and Wales, 7th Annual Report, 2010. Retrieved from:http://www.njrcentre.org.uk/NjrCentre/LinkClick.aspx?fileticket=QkPI7kk6B2E%3d&tabid=86&mid=523
2. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report, Adelaide: AOA, 2010. Retrieved from: http://www.dmac.adelaide.edu.au/aoanjrr/documents/aoanjrrreport_2010.pdf
3. Multi-center PINNACLE Acetabular Cup System Outcomes Study. Kaplan-Meier survivorship results. Abstract submitted for 2011 American Association of Hip and Knee Surgeons Meeting.