FDA Panel Recommends DePuy's Ceramic-on-Metal Hip for Approval
BY LAUREN UZDIENSKI, AUGUST 18, 2009
An FDA panel unanimously determined on Tuesday that DePuy's ceramic-on-metal hip, the Pinnacle CoMplete, is safe and effective, essentially recommending it for market approval. The panel also recommended modifying the labeling and undertaking a post-market study as conditions for approval. The FDA usually follows the panel's recommendation in making their final decision. If the device is approved, it will be the first ceramic-on-metal THA device available in the U.S.
The news follows somewhat disappointing clinical study data. A two-year controlled, randomized, blinded, prospective, multicenter clinical study found limited benefit for CoMplete compared with a metal-on-metal system. Endpoints included pain, function and complications, but ion production is receiving the most attention.
A potential downside of traditional metal-on-metal hips is ion production associated with device wear. The long-term effect of these ions is unknown, but for this reason, metal-on-metal devices are not recommended for use in women of childbearing age and patients with kidney problems. While the two-year DePuy study did not find reduced ion production with the metal-on-ceramic hip compared to metal-on-metal, alternative bearing surfaces are generally thought to offer a solution to the ion issue. Another benefit is product lifespan: the harder surface of a ceramic may make the device more durable, which is important as patients' life expectancy increases. Of course, these alternative surfaces have had their detractors as well. Concerns about ceramic-on-ceramic hips have included squeaking, and some explanted ceramic-on-ceramic components have shown signs of accelerated or stripe wear.
