Guest guest Posted February 19, 2002 Report Share Posted February 19, 2002 Patients given faulty hip replacement device NEW YORK, Jan 29 (Reuters Health) - Zimmer Holdings Inc. said on Monday that as many as 234 of its recalled femoral heads, or " hip balls " used in hip replacement surgery, were implanted in patients and have the potential to break over the next several years. In August 2001, Zimmer began recalling certain lots of femoral heads manufactured by France's Saint-Gobain Advanced Ceramics Desmarquest after they were linked to a higher-than-expected failure rate. The recall was only for unimplanted products, and the US Food and Drug Administration has recommended that implanted products not be removed unless they are causing problems. Zimmer said on Monday that it is asking its customers to notify patients about the possibility of breakage for the implanted femoral heads and advising surgeons to monitor the implants carefully. According to Zimmer, fewer than 100 of its 234 faulty implants were sold in the US, and only four have failed worldwide to date. A spokesperson for Zimmer told Reuters Health that the Warsaw, Indiana-based company has not been named in any lawsuits over the issue, and that it was too early to know whether the company would sue Saint-Gobain. A number of companies distributed the faulty Saint-Gobain products. Quote Link to comment Share on other sites More sharing options...
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