The Depuy ASR Hip Implant:
DePuy Orthopaedics, Inc. is a part of Johnson and Johnson and provides healthcare solutions to those in chronic pain, including hip replacement solutions. In recent years, rising complaints have surrounded DePuy's metal on metal hip prosthetics, the ASR XL Acetabular System and ASR Hip Resurfacing System. The ASR XL Acetablular hip is a one-piece metal cup and metal socket system, which is used for total hip replacement procedures. Following a rising volume of complaints, DePuy recalled all components for the ASR XL Acetabular System as well as the ASR Hip Resurfacing Platform.
The Depuy Pinnacle:
Although it has not been recalled, another of DePuy's hip prosthetic systems is also receiving significant negative attention: the DePuy Pinnacle Acetabular Cup System. The Pinnacle hip system is a modular acetabular system, which allows one to choose from a wide range of acetabular cup options. A mounting array of problems with the metal on metal version of the Pinnacle system has caused many to believe they are being exposed to the very same dangers as those with the ASR system.
Metal on Metal Hip Replacement Concerns and Risks:
Although the ASR Hip Resurfacing System was never approved in the U.S., the FDA approved the ASR XL Acetabular System and the Depuy Pinnacle via the "fast-track" substantially-similar 510(k) process. While many perceive FDA- approved products to be safe, those products approved through the 510(k) process actually undergo a very limited review prior to being placed on the market. If a manufacturer is able to show a product is substantially similar to another device already on the market, the FDA will approve the new product for sale without typically requiring clinical studies of the device's safety or efficacy. Depuy was able to gain expedited FDA approval for these devices via this process, thereby bypassing rigorous FDA pre-market approval testing and inquiry. The 510(K) process is under increasing fierce scrutiny, as the public protests against being test subjects for devices which never should have been approved.
The FDA first issued a recall notice concerning the Depuy ASR components on July 17, 2010. In August of 2010, DePuy recalled the ASR XL Acetabular System and the ASR Hip Resurfacing System. The failure rate for the ASR systems have been documented at 12-15% within the first five years, an unacceptable failure rate which far exceeds the anticipated15-20 year lifespan of an average hip replacement. DePuy issued a recall of some 93,000 ASR hip implants, but the recall came years after complaints and after it had already been announced that the company was phasing out the ASR system as a result of decreased sales.
Common Complaints related to the DePuy Hip Replacements ASR systems include the following:
- Premature ASR hip system failure, and the need for revision surgery
- Unexplained Hip Pain
- Popping/grinding noises
- Swelling and inflammation of tissue surrounding the implant
- Difficulty walking
- Elevated levels of metal in the body and bloodstream
- Loosening and dislocation of the implant
- Bone Fractures
- Soft tissue reactions to metal debris within the body
Complaints related to DePuy Pinnacle are similar to those for the ASR system.
The FDA is continuing to monitor metal on metal hip implants, and has announced that it will re-examine the safety of all-metal artificial hips with an expert advisory panel in June of 2012.
Upcoming Deadline to File a Depuy Hip Replacements Legal Claim:
In California as in many other states, the legal deadline (statute of limitations) to file a personal injury or product liability claim is 2 years from the date of injury, or two years from the date the injury and its wrongful cause could reasonably have been discovered. As such, it is likely that the deadline to file a claim for DePuy ASR hip implants is August 23, 2012, as this is two years from the August 24, 2010 date when DePuy's recall notice became widely publicized.
Those who are experiencing any of the complaints discussed above should promptly contact a malpractice attorney, to avoid having the claims being forever timed barred. Further, those who have a DePuy ASR hip implant but who are not yet experiencing negative symptoms should also take immediate steps to protect their rights. It is anticipated that DePuy/Johnson & Johnson may take the position that a person suffered an injury at the time the defective hip was implanted, and that they knew, or should have known, about the injury at the time the recall was announced in August of 2010. This is why the August 23, 2012 date could be important.
Call Us At 858-480-6182
If you have had a hip replacement or resurfacing procedure and are uncertain which type of device was used your physician or our office can assist you in this determination. Our law office of O'Mara and Padilla is accepting DePuy ASR and DePuy Pinnacle cases on a contingency fee basis. We invite your call for a free legal consultation with a malpractice attorney. Depending on the harms you have experienced you may be entitled to compensation.