Zimmer officials said they are taking this voluntary action to "address [company] concerns regarding reports of cup loosenings and revisions of the acetabular component used in total hip replacement procedures in some patients who have been implanted with the Durom Cup in the United States." This new information regarding the dangers of metallosis will also affect the current proceedings. The FDA has now asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are. Many individuals require a Zimmer hip revision surgery, which is a lengthy, painful process.
The Durom cup has been implanted in more than 12,000 U.S. patients since it was launched in the United States 2 years ago. The Durom Cup will continue to be marketed without interruption outside the United States, despite the FDA’s concerns. While Zimmer denies the device is defective, in a letter to orthopedic surgeons dated July 22, 2008, it acknowledged that some patients receiving the artificial hip implant may require revision surgery. Critics of the device fear that thousands of patients may require implant replacement. Potential plaintiffs who have any questions in regards to Zimmer hip litigation and filing a lawsuit of their own should first speak to an experienced Zimmer hip lawyer.