According to a recent review of its Adverse Event Reporting System, (AERS) database, 709 Pinnacle Hip Implant adverse event reports,(AERs), were submitted in the last three months (July-September.) Of these, 201 DePuy Pinnacle Hip problems were reported, regarding metal-on-metal liner This brings the total number of Pinnacle Hip Implant AERs made to the FDA this year to 1,266 (450 confirmed metal). If this trend continues, DePuy is on track to have over 1,700 Pinnacle AERs (with more than 600 confirmed metal) by the beginning of next year. In addition to defending the DePuy Pinnacle hip implant lawsuits, Johnson & Johnson and DePuy also face thousands of lawsuits over the DePuy hip recall of their ASR hip system,
which was pulled from the market in August 2010 due to a higher-than-expected failure rate. The DePuy ASR hip was approved as a substantial equivalent design to the DePuy Pinnacle metal-on-metal hip, and the allegations raised regarding design problems with the two devices are similar.
Design problems with metal-on-metal hip implants, and particularly the DePuy ASR hip and DePuy Pinnacle, can cause the metal components to rub against each other and shed microscopic metal particles into the body. Reactions to these metal particles can cause soft tissue damage, cause inflammatory reactions and lead to bone loss. This can compromise the hip replacement, potentially leading to the need for painful and risky hip revision surgery. The metal particles shed from metal-on-metal hip replacement implants can increase the amount of some metals in the blood, such as chromium and cobalt. This can lead to DePuy hip metallosis, a type of blood poisoning, and genotoxicity, which can lead to genetic damage. Chromium and cobalt have also been linked to cancer, and could lead to the development of tumors.
Although no Pinnacle hip recall has been issued as of yet, last October, the American Academy of Orthopaedic Surgeons (AAOS) issued a warning about potential problems with metal on-metal hip replacements, indicating that patients and the medical community should be aware that pain months after hip replacement surgery may be a sign of metal-on-metal hip cobalt toxicity. Such cases have been filed in the United States District Court for the Eastern District of Louisiana and the U.S. District Court for the Middle District of Tennessee.
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