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DePuy Orthopaedics to Face More Lawsuits in Montre |
Even in Canada, recipients of the defective hip implants from DePuy Orthopaedics are enraged. The metal-on-metal hip implants, specifically the ASR XL Acetabular System and the ASR Hip Resurfacing System, are currently the subject of major scrutiny in Quebec because of their high failure rate of around 13%. There are even speculations that DePuy already knew that their hip implants were bound to fail after only a few years of use. After all, the ASR devices never really underwent clinical testing procedures set forth by the Food and Drug Administration. DePuy, apparently, used an ambiguity in the 510(k) regulatory process of the FDA, and claimed that their implants were ‘substantially equivalent’ to previously approved implants. Since 2003, over 93,000 Americans have chosen the ASR devices to replaced their damaged hip joints. When complaints started to take their toll on the company, the DePuy hip recall was issued. |
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Разгледан: 1471 | Размери: 250x250px/9.0Kb | Рейтинг: /Дата: 26.12.2010
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