The Depuy Pinnacle Hip Replacement Systems New Problems
When DePuy Manufacturing was formed in the late 1800s as a splint manufacturing company, its founders never could have envisioned that it would develop into an industry giant. DePuy, which was purchased by Johnson & Johnson in 1998, earns roughly $5 billion in annual revenue from its sales of medical devices. The company is not without its issues, however. Because the ASR hip replacement system was determined to be prone to failure in patients, DePuy ordered a recall of the product and may be facing a mountain of litigation.
The U.S. Food and Drug Administration (FDA) approved the DePuy ASR for sale to the public through the 510(k) approval process. The 510(k) process has been heavily criticized for having too loose standards for companies to meet in order to gain approval to bring a product to market. Under the 510(k) standard, a company must simply show that the product is substantially similar to a previously approved device. The device on which the ASRs approval was based was the DePuy Pinnacle hip replacement system. Now, the Pinnacle system is coming under heavy scrutiny from some circles that are concerned with the products inherent risks.
There have been over 500 reported complaints regarding the Pinnacle system, according to the FDA. Most of these complaints have to do with the product loosening prematurely. However, a New York Times report published in 2010 brought to light a potentially very serious issue. It turns out that metal-on-metal hip replacements such as the ASR and Pinnacle could carry the risk of causing metal toxicity in the host patient.
Metal-on-metal hip replacement systems have metal components that rub against each other in contrast to regular hip replacement systems that typically utilize a synthetic plastic liner inside the socket part of the synthetic joint. As the components rub against each other, metal particles may flake off and embed themselves in the soft tissue surrounding the device or enter the bloodstream and spread throughout the body. If enough of the substance builds up in the body of the patient, then he may suffer from metal toxicity, the symptoms of which are very vague but may include disorientation and feelings of general malaise.
If you have suffered from metal poisoning or loosening in your Pinnacle device, you may have the basis for a Pinnacle lawsuit. The hard-working attorneys at the Rottenstein Law Group are equipped with a total of over 25 years of experience and the know-how to get you the restitution you deserve.
The U.S. Food and Drug Administration (FDA) approved the DePuy ASR for sale to the public through the 510(k) approval process. The 510(k) process has been heavily criticized for having too loose standards for companies to meet in order to gain approval to bring a product to market. Under the 510(k) standard, a company must simply show that the product is substantially similar to a previously approved device. The device on which the ASRs approval was based was the DePuy Pinnacle hip replacement system. Now, the Pinnacle system is coming under heavy scrutiny from some circles that are concerned with the products inherent risks.
There have been over 500 reported complaints regarding the Pinnacle system, according to the FDA. Most of these complaints have to do with the product loosening prematurely. However, a New York Times report published in 2010 brought to light a potentially very serious issue. It turns out that metal-on-metal hip replacements such as the ASR and Pinnacle could carry the risk of causing metal toxicity in the host patient.
Metal-on-metal hip replacement systems have metal components that rub against each other in contrast to regular hip replacement systems that typically utilize a synthetic plastic liner inside the socket part of the synthetic joint. As the components rub against each other, metal particles may flake off and embed themselves in the soft tissue surrounding the device or enter the bloodstream and spread throughout the body. If enough of the substance builds up in the body of the patient, then he may suffer from metal toxicity, the symptoms of which are very vague but may include disorientation and feelings of general malaise.
If you have suffered from metal poisoning or loosening in your Pinnacle device, you may have the basis for a Pinnacle lawsuit. The hard-working attorneys at the Rottenstein Law Group are equipped with a total of over 25 years of experience and the know-how to get you the restitution you deserve.
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