At the end of August, DePuy Orthopedics, Inc., an operating company of Johnson & Johnson, voluntarily recalled its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. The Acetabular system was a traditional hip socket replacement, while the Hip Resurfacing System was a partial replacement system involving placing a metal cap on a patients femur. First becoming available in July of 2003, Surgeons preferred using DePuy ASR devices for younger patients because of their larger structure diameter, which enhanced stability. The Food and Drug Administration (FDA) had been receiving complaints about the devices for over two years and recently warned the company for using their hip replacement devices for non-FDA approved uses. Over 400 complaints were received in 2010 alone. DePuy included over 93,000 units in its recall, mostly due to loosening of the implant, bone fracture, or implant dislocation. Often patients reported needing revision surgery due to these problems, a painful and costly procedure. According to DePuys own statistics, 1 in 12 patients who received the resurfacing device and 1 in 13 patients who had a complete replacement required corrective surgery.
Not an Easy Fix
Many patients required revision surgery for a second hip implant five years after having the first hip replacement device implanted. Most surgeries are the result of debris caused from the wear and tear of the devices metal parts. As a result, some patients reported pain and swelling around the bone. Other patients allege toxic particles excreted from the device prevented it from properly fusing to their bones. Some were unable to receive a replacement device, leaving them unable to walk and bringing their lives to a standstill. Although DePuy estimates around 10,000 patients will need revision surgery due to these devices, the true number is still unknown. In 2009, DePuy claimed they were no longer planning to produce the implants due to poor sales. In March of 2010 DePuy warned doctors of low success rates with the implants. However, at that point DePuy had already been served with lawsuits alleging that there were defects in their hip implant products. DePuy has stated they will cover reasonable medical costs associated with the ASR devices including monitoring, doctor visits, and revision surgeries.