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
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hip replacement.