First Ceramic-on-Metal Hip Replacement Approved2011-Jun-14
By -- Scott Roberts
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.
Medline Plus has more about hip replacement.
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