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Patients given faulty hip replacement device

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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.

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