FDA Poised to Approve Depuy Orthopaedics First Ceramic-On-Metal Hip Replacement for U.S. Market
| Depuy Orthopaedics, www.depuy.com |
An FDA advisory panel has recommended approval of a ceramic-on-metal hip replacement from Depuy Orthopaedics, Warsaw, Ind. It is believed the FDA will approve the new implant, the Pinnacle CoMplete Acetabular Hip System, by next month, making it the first such hip implant in the U.S.
Until now, American hip replacements had a ball-and-socket design that involved metal-on-metal contact. The problem has been that this contact puts wear on the metal components and metal ions end up in the patient’s blood stream. Pregnant women and people with kidney disease, among other potential implant candidates, have been advised against metal-on-metal artificial hips because of concerns about metal ions.
In two years of testing, the new hip replacement showed 90% less wear than metal-on-metal designs under normal walking conditions. The reduction in wear went to 80% among patients who ran or put “more than normal” stress on their hips.
The Pinnacle implant is already available in 40 countries outside the U.S., according to Depuy.