DePuy Hip Implant Warnings Issued Many Times Prior to Recall

Should DePuy Orthopaedics have issued a DePuy hip recall of its ASR XL System years ago? According to a report in the Advertiser out of Australia, regulators there warned DePuy multiple times since 2007 that the ASR XL Acetabular Hip Implant was prone to early failure.

A commentary written by Professor Stephen Graves, head of Australia’s National Joint Replacement Registry (NJRR), asserts that J&J was contacted “at least 17 different occasions” about <"">DePuy hip implant problems.

This is not the first time Graves has slammed DePuy for its handling of the ASR XL Acetabular hip implant. We reported earlier this year that Graves told the UK Independent that DePuy had behaved “irresponsibly and very badly,” putting patients needlessly at risk. “It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people,” Graves said at the time.

Incidentally, DePuy pulled the ASR XL Acetabular Hip Replacement System from the Australian market in December 2009. But the company waited to warn doctors and patients in the US and elsewhere.

According to US Food and Drug Administration (FDA) records, since early 2008, it received about 300 complaints against DePuy on the ASR involving patients in the this country. DePuy first notified US doctors that there were problems with the ASR system in March 2010. Then in August, DePuy issued a worldwide recall for the ASR XL Acetabular Hip Replacement System 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 then, more than 93,000 patients worldwide were fitted with an ASR hip implant.

The DePuy Acetabular Hip Replacement System is a metal-on-metal hip implant made of chromium and cobalt, the device consists of a cup that’s implanted into the hip with a ball joint that connects to the leg. It is believed that many of the complications linked to the DePuy ASR XL Acetabular hip implant are caused by wearing of the metal components, which can allow metal shavings to make their way into patients’ bloodstreams. According to a report by ABC News, the resulting cobalt poisoning could increase the risk of a number of heath problems, including dementia and heart failure. DePuy now recommends that implant patients have a blood test to check for high levels of chromium and cobalt.

Since the recall, around 150 lawsuits have been filed against DePuy by victims of the ASR hip implant, and many more such suits are expected. Recently, all federal lawsuits involving the DePuy ASR XL Acetabular Hip Replacement System were consolidated in a multidistrict litigation in the US District Court for the Eastern District of Ohio.

This entry was posted in Defective Medical Devices, Depuy. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.