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28 Jan 2015

DePuy Pinnacle Device Failure Does Not Prompt Recall

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There has yet to be a recall on Johnson & Johnson’s Pinnacle hip replacement system, despite thousands of lawsuits being filed against the company. The Pinnacle system, developed by J&J’s DePuy division, was designed to be able to withstand a heavy load for those wishing to pursue an active lifestyle. Unfortunately, due to multiple failures of the device to perform as intended, the line was discontinued by Johnson & Johnson. There has yet to be a manufacturer issues recall yet, however.

The Pinnacle system comes with several surfacing options for the individual and doctor to chose based on the situation. These include metal-on-metal and ceramic-on-metal versions. These options were made available so that the device can be tailored to the individual needs and lifestyles of the patients.

As it turns out, the surfacing used in the Pinnacle system is extremely dangerous to patients and contains a high risk of failure. The failures occur when the implant rubs together during regular walking or running activities, resulting in cobalt and chromium particles entering the bloodstream. The condition where metal enters the bloodstream is referred to as metallosis, and can be very dangerous. Additionally, the implant can loosen and fall out of it’s intended place. These complications can lead to joint swelling, infection, and chronic pain. Other symptoms include bone deterioration, tissue death, nerve damage, and inflammation. Usually, these complications result in the patient needing to undergo revision or replacement surgery to repair the failed implant and the damage it caused.

The U.S. Food & Drug Administration approved the Pinnacle system quickly because of it’s similarity to an already existing product produce by Johnson & Johnson. It did not undergo rigorous and extensive clinical trials. Johnson & Johnson has recalled other metal-on-metal hip devices, but have yet to issue a recall for their Pinnacle product line.

The failure by Johnson & Johnson to recall this device has resulted in thousands of patients suffering. Federal district courts have seen thousands of cases filed against these dangerous devices. More and more patients are finding their Pinnacle hip systems to fail, and are faced with mounting medical costs due to additional corrective surgeries.

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