DePuy ASR hip replacement recalled in U.S. five years after problems first detected in Australia

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Oct 20, 2011 -
Despite knowledge that the DePuy ASR hip replacement systems were failing in Australian patients, the device was not pulled from the market until three years later.

According to the Sydney Morning Herald, Senate testimonies held in Australia last month revealed that patient complications surrounding the DePuy ASR were reported to the Therapeutic Goods Administration (TGA), but nothing was done to prevent others from having the faulty device implanted. Similar to the Food and Drug Administration, or FDA, the Therapeutic Goods Administration is Australia’s regulatory agency for medical drugs and devices.

The head of Australia’s National Joint Replacement Registry, Professor Stephen Graves, testified at the hearing that he was concerned about the amount of time it took for the TGA to take action, after they were told by the Joint Registry that there was 50 percent higher rate in repeat surgery involving the DePuy ASR. Click to read the full Sydney Morning Herald article on the DePuy ASR hip recall.

Professor Graves also went on to mention that roughly 5,000 DePuy ASR patients have had to undergo revision surgeries. It is estimated that one out of every eight Australian patients with an ASR will have to undergo a revision surgery within five years of their original hip replacement.

It is hard to determine how many U.S. DePuy ASR patients will have to undergo revision surgeries, since a national joint registry is not yet in place, although there are plans in the making for creating one. (Click for more information ZKB Law’s coverage of a national joint registry for the United States). But what is troublesome is the fact that the DePuy ASR was recalled in America nearly two years after the recall in Australia, which also means that the American recall happened nearly five years after problems were first detected in the ASR.

If you need more information on the recalled device, or you are having complications from a DePuy ASR hip replacement, contact us toll-free at 888.841.9623 or via email at Michelle@toledolaw.com.
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ZOLL, KRANZ & BORGESS, LLC is an advocate for pharmaceutical drug/device safety and a recognized leader in nationwide litigation involving defective medical drugs and devices, as well as other types of Multidistrict (“MDL”) & Class Action Litigation. Call us toll-free at 888.841.9623 for more information or visit our website, www.ToledoLaw.com.