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Australian Regulators Issued Warning on Recalled DePuy ASR Hip Implant in 2007

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How long did DePuy (Johnson and Johnson subsidiary) know about problems with its ASR hip implant system? Would you believe about three years before it finally issued a recall of the defective hip replacement (namely DePuy ASR hip implant) this past August?

Sadly, that’s true according to a report from the UK-based Independent. The newspaper is reporting that starting in 2007, the Australian Joint Registry – the second largest such registry in the world – issued seven reports to DePuy that identified problems with the hip implant system. The ASR system was finally withdrawn from the Australian market in December 2009.

Professor Stephen Graves, director of the Australian National Joint Replacement Registry, told the Independent that DePuy had behaved “irresponsibly and very badly,” putting patients needlessly at risk.

In March, DePuy Orthopaedics warned US Doctors that the ASR appeared to have a high early failure rate, but it waited until August to issue the recall. According to U.S. Food and Drug Administration (FDA) records, since early 2008, it received about 300 complaints on the ASR involving patients in the U.S.

The DePuy ASR implant was finally recalled in August after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the recalled devices had to undergo revision surgery within five years of receiving it. By the time the recall was issued, 93,000 patients worldwide had received a defective DePuy ASR hip implant.

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