The worldwide reach of the DePuy ASR Hip Implant recall was highlighted this week by a report out of New Zealand regarding a spike there in the number of hip replacement patients who have had the faulty devices removed. According to a report from NZHerald, the most recent figures from the country’s hip registry indicate that 23 percent of those implanted with the DePuy ASR XL Acetabular Hip Implant for total hip replacement had the device removed. In December 2010, the number stood at just 7 percent.
DePuy Orthopaedics, a division of Johnson & Johnson, recalled the ASR XL Acetabular Hip Implant and the ASR Hip Resurfacing System were finally recalled in August 2010, after data from a medical device registry in the U.K. indicated that they were failing in about 12 of patients within five years. At the time the devices were recalled, some 93,000 patients worldwide received one of the ASR models.
According to the NZHerald report, 10 percent of New Zealanders who received the ASR Hip Resurfacing System have had those removed.
NZ Orthopaedic Association president Bryan Thorn told NZHerald that not every ASR recipient who underwent a revision may have had a medical need. Some may have decided to have their implant removed because they were wary of the recall, while others likely tested positive for elevated levels of chromium and cobalt in their blood.
In the U.S., only the DePuy ASR XL Acetabular Hip Implant was approved for sale. That device was cleared by the Food & Drug Administration (FDA) in 2005 under the agency’s 510(k) program, which does not require human testing if a device is shown to be substantially equivalent in design to an already approved product. The ASR Hip Resurfacing System was not eligible for that program, however, because hip resurfacing was a new procedure.
In September 2009, the FDA issued a non-approval letter for the ASR hip resurfacing system that requested more safety data from DePuy. According to a New York Times report published last week, the letter expressed concerns about elevated levels of metal ions seen in the blood of some DePuy ASR hip implant recipients. The FDA also wrote that reports from countries where the implant was then being used showed it was performing “somewhat more poorly” than data submitted to the agency by the DePuy indicated.
According to the Times, DePuy never provided the data requested by the FDA. Despite the concerns raised in the letter about the performance of the ASR hip resurfacing device, the company continued to sell it abroad. However, in September 2009 – just weeks after receiving the FDA non-approval letter – DePuy executives decided to phase out sales of both ASR Hip implant devices. The company announced the move in November 2009, blaming the decision on slowing sales of the products.