Previous total hip replacement systems cleared by the U.S. Food and Drug Administration have used different combinations of metal, ceramic, and polyethylene. A new FDA-approved Pinnacle CoMplete Acetabular Hip System, from DePuy Orthopaedics Inc, Warsaw, Ind, is the first total artificial hip system for patients with osteoarthritis to combine a ceramic ball and a metal socket.
"Orthopedic surgeons and their patients now have an additional option for total hip replacement with the approval of the Pinnacle CoMplete Acetabular Hip System," said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
The FDA’s approval is based on a two-year, randomized clinical trial, which found no clinical difference between 194 patients who received the new ceramic-on-metal system and 196 patients in a control group who received a metal-on-metal hip implant. Two patients who received the Pinnacle CoMplete system required a second surgery to replace their new implant compared with three patients who required a second surgery in the control group.
As a condition of FDA approval, DePuy Orthopaedics will conduct a post-market study, monitoring patients receiving the Pinnacle CoMplete system for adverse events and metal ion concentrations in their blood.