First Ceramic-on-Metal Hip Implant Approved

On June 13, the FDA approved the first ceramic-on-metal total artificial hip replacement for individuals with osteoarthritis. With the approval of the DePuy Pinnacle CoMplete Acetabular hip system, doctors now have an additional option for total hip replacement surgery.

As metal-on-metal hip replacements wear, they can release small metallic particles into the bloodstream and tissue, potentially causing bone loss, pain and tissue death.

Previously, hip replacements approved by the FDA used different combinations of ceramic, metal and polyethylene, a form of plastic. Over recent years, patients receiving hip implants consisting of a metal-on-metal ball and socket complained of problems, including hip implant loosening and unexplained hip pain. Furthermore, patients receiving metal-on-metal hip implants, including the ASR hip implant which was implicated in a 2010 DePuy hip recall, were reportedly put at risk due to the metal-on-metal nature of the hip replacements. Reportedly, as metal-on-metal hip replacements wear, they can release small metallic particles into the bloodstream and tissue, potentially causing bone loss, pain and tissue death. In some cases, patients who developed hip implant metal poisoning needed a painful revision surgery to remove the implant.

Although the newly approved Pinnacle CoMplete Acetabular hip system consists of both metal and ceramic particles, DePuy is still required to conduct a post-market study to monitor patients for adverse events and metal ion concentrations in their blood.