Having surgery, especially for a hip replacement, presents many challenges for a person in terms of recovery and rehabilitation. Because patients trust that medical device manufacturers have properly tested and designed their products, ensuring they are effective and safe, most people don’t think twice about the quality or condition of the device being used for their knee, or hip replacement. However, as the infamous DePuy hip implant device recall demonstrates, this trust has the potential to be broken.
DePuy Orthopaedics, Inc., a Johnson & Johnson subsidiary, announced a voluntary recall of its ASR™ XL Acetabular Systems and DePuy ASR™ Hip Resurfacing Systems after receiving reports that many patients needed corrective, secondary surgery to replace their hip implant device due to failure. The National Joint Registry (NJR) of England and Wales supplied data from 2010 that reflected a five-year revision rate of approximately 12 percent for the ASR™ Hip Resurfacing System and approximately 13 percent for the ASR™ XL Acetabular System.
Introduced in 2003, the DePuy ASR™ Hip Resurfacing System was only been approved for use outside the United States. On the other hand, the ASR™ XL Acetabular System was launched in 2004 and was distributed worldwide. The ASR device was preferred by orthopedic surgeons for young patients who were thought to benefit the most from the stability of the device, therefore lowering the odds of problems with dislocation.
The need for revision hip surgery in patients with affected DePuy implants stems from complications such as hip system failure, hip implant device becoming loose, excessive hip pain or discomfort, weakness, and swelling. Some of the most serious side effects of the DePuy hip implant devices include tumors around the implant as well as metal fragments from the implant entering the bloodstream and causing an increased risk of blood clots and heavy metal poisoning.
The U.S. Food and Drug Administration (FDA) noted about 400 complaints from patients in 2008 in regards to catastrophic injuries do to the failure of DePuy hip replacement devices. It was at this time that a 13 percent revision surgery rate was reported, a rate significantly greater than most hip replacements. Nevertheless, it wasn’t until 2009 that DePuy removed the ASR hip systems from the market in Australia. The devices continued to be sold in the U.S. until the end of 2010.
Orthopedics is not only a necessary branch of medicine; it’s also a billion dollar industry. There are instances when a person experiences extreme arthritic pain or suffers an injury and there’s no way of avoiding hip replacement surgery. A person doesn’t just bounce back from this type of procedure; it takes weeks, if not months, before they can return to normal in regaining strength and mobility.
While some discomfort is to be expected from hip replacement surgery, if you have suffered serious side effects or experienced complications, you should consult with your doctor to see if revision hip implant surgery is necessary. You may also wish to speak with a Las Vegas personal injury lawyer who has experience protecting the rights of individuals harmed by defective medical devices and implant systems.
At Shook & Stone, our Nevada defective product lawyers are committed to ensuring the best possible outcome for our clients. We have the resources and skills to build strong, effective cases so that negligent manufacturers don’t get off the hook for acts of oversight and negligence. To learn more about how we can help, call 702-570-0000 for a free consultation.