DePuy ceramic-on-metal hip replacement gets FDA nod

By Dr. Ananya Mandal, MDJun 15 2011

The Food and Drug Administration has approved the first ceramic-on-metal total artificial hip system for osteoarthritis patients, a device made by Johnson & Johnson's DePuy Orthopaedics unit, the agency said Tuesday. The Pinnacle Complete Acetabular Hip System, combining a ceramic ball and a metal socket, has been sanctioned for people with osteoarthritis, the agency said in a news release.

This will allow orthopedic surgeons and patients an additional option when considering total hip replacement surgeries. For these surgeries the worn and damaged portions of bone and cartilage are removed and replaced with an artificial joint. Existing hip replacement systems use different combinations of metal, ceramic and a form of plastic called polyethylene.

Approval was based on a two-year study that found no clinical difference between 194 people who received the new ceramic-on-metal system and 196 people who received a metal-on-metal device, the FDA said.

This new implant will be the first to combine a ceramic ball and a metal socket. As a condition of the approval, DePuy will conduct a postmarket study, monitoring patients for adverse events and metal ion concentrations in their blood, the FDA said.