New Problems Surrounding the DePuy Pinnacle Hip Replacement Systems
Back
in the late 1800s when DePuy was formed as a splint manufacturing company, its
founding fathers could never have imagined that it would become the industry
leader it is today. Even when it was acquired by Johnson & Johnson, DePuy
became a major asset and has earned $5 billion in annual revenue from sales of
its medical devices. However, the company has suffered some setbacks. DePuy’s
ASR hip replacement system has been found to have a high failure rate in
recipients, leading the company to order a recall of the product in the face of
litigation. Just recently, the Pinnacle system has begun receiving complaints
which could also lead to a number of DePuy Pinnacle lawsuits.
One underlying factor leading to the massive recall and the numerous lawsuits is the loophole in the approval process of these products. The U.S. Food and Drug Administration (FDA) allowed the marketing of the DePuy ASR system to the public through the 510(k) approval process. Under this process, a company needs only to demonstrate that their product is “substantially equivalent” to a previously approved device. The ASR system’s approval was based on its similarity with the DePuy Pinnacle hip replacement system currently on the market. The Pinnacle system is now receiving criticism from a number of groups concerned with the inherent risks of the product.
According to the FDA, there have been over 500 reported complaints regarding the Pinnacle system. While most of these complaints have been about the device loosening prematurely, a New York Times report published in 2010 has focused on the serious risk of metal toxicity. In contrast to a typical hip replacement system that utilizes a synthetic plastic liner inside the socket part of the synthetic joint, both the ASR and Pinnacle systems are metal-on-metal devices that carry the increased risk of metal toxicity due to the friction of their metal components causing release of metal particles into the bloodstream. Build up of these metallic particles may cause the patient to suffer symptoms of metallosis, which are very vague but may include disorientation and feelings of general malaise..
New problems associated with the Depuy Pinnacle systems may lead to numerous lawsuits. Recipients suffering from symptoms of metallosis or loosening of the Pinnacle device may have the basis to pursue a Pinnacle lawsuit and should seek legal consultation. Visit the DePuy Pinnacle lawsuit website for more information.
One underlying factor leading to the massive recall and the numerous lawsuits is the loophole in the approval process of these products. The U.S. Food and Drug Administration (FDA) allowed the marketing of the DePuy ASR system to the public through the 510(k) approval process. Under this process, a company needs only to demonstrate that their product is “substantially equivalent” to a previously approved device. The ASR system’s approval was based on its similarity with the DePuy Pinnacle hip replacement system currently on the market. The Pinnacle system is now receiving criticism from a number of groups concerned with the inherent risks of the product.
According to the FDA, there have been over 500 reported complaints regarding the Pinnacle system. While most of these complaints have been about the device loosening prematurely, a New York Times report published in 2010 has focused on the serious risk of metal toxicity. In contrast to a typical hip replacement system that utilizes a synthetic plastic liner inside the socket part of the synthetic joint, both the ASR and Pinnacle systems are metal-on-metal devices that carry the increased risk of metal toxicity due to the friction of their metal components causing release of metal particles into the bloodstream. Build up of these metallic particles may cause the patient to suffer symptoms of metallosis, which are very vague but may include disorientation and feelings of general malaise..
New problems associated with the Depuy Pinnacle systems may lead to numerous lawsuits. Recipients suffering from symptoms of metallosis or loosening of the Pinnacle device may have the basis to pursue a Pinnacle lawsuit and should seek legal consultation. Visit the DePuy Pinnacle lawsuit website for more information.
