Every year, approximately 250,000 people in the U.S. receive hip replacement implants. Of these, nearly 1/3 receive a metal-on-metal hip implant device. In 2005, the FDA approved the use of a metal-on-metal device manufactured by DePuy, a division of Johnson & Johnson. By 2010, however, the FDA had received more than 300 complaints regarding the DePuy ASR Hip Replacement devices.
The DePuy ASR System was determined to be defective, but only after thousands of people had already received hip replacement implants with the device. A regulatory pathway that did not require clinical trials for FDA approval cleared the ASR Hip Replacement without adequate testing and research. Many patients have had to undergo follow-up operations to replace the device within a few years, while typical hip replacement implants are expected to last 15 years or more.
The DePuy ASR Hip Replacement Design Flaw
The DePuy ASR is now believed to have a design flaw that makes the device difficult to be implanted properly. The problem appears to be caused by the ASR cup being shallower than other hip replacement devices. Other problems associated with the metal-on-metal design of the DePuy ASR Hip Replacement include the potential for large amounts of metal debris to be generated during normal wear.
The defective DePuy ASR Hip Replacement device has been associated with problems such as:
· Severe inflammatory responses to metal debris
· Damage to muscles and soft tissue
· Continued pain or discomfort more than 3 months after implant surgery
· Difficulty walking
· Migration, loosening or dislocation of the implant
· Additional hip replacement or revision surgery
DePuy’s Warning and Hip Replacement Recall
In response to the higher-than-expected failure rate, DePuy announced in late 2009 that it planned to phase out sales of the ASR devices worldwide by the end of 2010. On March 10, 2010, DePuy issued a warning letter to doctors to report problems with their ASR device on certain types of patients as indicated by data collected in Australia. The data revealed that 13% of patients (1 in 8) who had received the DePuy ASR Hip Replacement needed revision surgery after just five years from the original implant.
In July and August of 2010, DePuy voluntarily recalled the ASR System, including the DePuy ASR Cups, the ASR XL Acetabular Head System, and the ASR Hip Resurfacing System (non approved in the U.S.). The recalls affected nearly 93,000 units that had been in production since 2003.
DePuy made a commitment to pay medical costs associated with the recalls, including the costs for a replacement hip implant. However, reimbursements for patients have been limited to out-of-pocket costs and DePuy has not agreed to compensate for lost wages, disability, pain, tissue damage or bone damage caused by the implantation of the DePuy ASR device or the revision surgery to replace the DePuy ASR device.
Complications from a DePuy ASR Hip Replacement?
Cases involving patients who have suffered damages or injury from a defective DePuy ASR Hip Replacement are currently being investigated. If you or a loved one has questions about your case, and especially if you have received a revision surgery, please contact Lieser Law Firm today for a free legal consultation.