An estimated 250,000 hip replacements occur each year in the United States on patients of every age. DePuy Orthopaedics, a division of Johnson & Johnson, services a significant portion of this market. Hundreds of thousands, perhaps millions, of patients have invested their trust in the company to put together a quality product that will serve their specific needs following life-changing hip replacement surgery. Recently, some evidence has come to light that indicates that trust in Johnson & Johnson and DePuy may have been misplaced.
A year ago, DePuy’s ASR Hip Resurfacing System and ASR Acetabular System began to make headlines as evidence emerged that the hip implants were failing a high rate. An estimated 12% of the systems were experiencing failure within five years, a rate that is completely unacceptable within the medical device industry. This finding prompted the U.S. Food and Drug Administration (FDA), the administrative body responsible for approval of bringing medical devices to market, to request a recall of DePuy’s ASR Hip Resurfacing System and ASR Acetabular System. This was bad news for more than just recipients of the ASR systems that were recalled. The DePuy ASR system was approved by the FDA through the Section 510(k) approval process, which grants pre-market approval to medical devices based upon substantial similarity to existing approved medical devices. The ASR’s approval was based on its substantial similarity to another DePuy product—the Pinnacle hip replacement system.
Unfortunately, many recipients of Pinnacle implants have reported suffering severe pain as a result of loosening where the metal ball fits in the metal cup of the replacement joint.
One plaintiff filed a case against DePuy and Johnson & Johnson in United States District Court in California on November 30, 2010. The complaint alleges that loosening of the shaft where the ball fits into the cup has led to her suffering severe nerve pain, which has led to the development of such side effects as an abnormal gait, resulting in her needing revision surgery on her hip. Several other people have come forward with complaints of pain that is likely related to loosening of the hip replacement system in some way. The pain described is debilitating due to its severity and chronic nature, as it arises when doing simple tasks such as leaning forward, standing up, sitting down, and straightening the legs.
If you have a DePuy pinnacle hip replacement system and have suffered loosening, pain, or any other problems, you may have a claim against Johnson & Johnson and DePuy. The lawyers of the Rottenstein Law Group have 25 years of experience defending clients who have suffered after misplacing their trust in negligent companies that produce harmful products. For a free consultation with RLG, please fill out this contact form.