Back in 2006, Wright Medal Inc. took steps to convince the FDA to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, who manufacturers the Conserve and the Lieneage hip replacement devices, also filed a citizen petition with the FDA asserting that Smith & Nephew’s pre-market approval application was inadequate to prove the true safety and effectiveness of the Birmingham. The company alleged that the clinical data backing the Birmingham application was faulty because it covered only a single surgeon’s cases. Nevertheless, the FDA eventually granted two-premarket approvals for the Birmingham, first in May 2006 and another in October 2006 for additional implant sizes.
The Birmingham metal-on-metal hip implant first came to market in 1997 in the UK making waves for being the first all-metal device on the market. The launch of the Birmingham prompted other device manufacturers to quickly bring their versions of metal-on-metal hip implants to the market, such as the Zimmer Durom Cup and DePuy’s ASR and Pinnacle devices.