First Ceramic-on-Metal Hip Replacement Approved

TUESDAY, June 14 (HealthDay News) — The first ceramic-on-metal total hip replacement system has been approved by the U.S. Food and Drug Administration.

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.

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.

The maker of the new device, DePuy Orthopaedics, is required to conduct a post-approval study to evaluate any long-term adverse effects and metal ion concentrations in the blood, the agency said.

DePuy is based in Warsaw, Ind.

More information

Medline Plus has more about hip replacement.

– Scott Roberts

Last Updated: June 14, 2011