DePuy Orthopaedics announced Thursday that the U.S. Food and Drug Administration 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. A multi-center clinical study conducted by leading orthopaedic surgeons showed that 96.1 percent of Pinnacle® hips are still in use eight years after surgery.
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.
