DePuy Orthopaedics, a Johnson & Johnson Company, has manufactured more than 150,000 Pinnacle hip replacement systems since first launching the device in 2001.  Since then, it is estimated that over 1,300 adverse events have been reported to DePuy Orthopaedics regarding its Pinnacle hip system failures. This apparently high-failure rate prompted the FDA to propose identification among medical devices, including hip implants.


A total hip replacement is a procedure in which the diseased cartilage and bone of the hip joint are replaced with an artificial device, like the DePuy Pinnacle hip.  The Pinnacle hip implant consists of a metal femoral head that often rotates against a metal liner called “Ultamet.”  Research has shown that metal-on-metal hip replacement systems can lead to serious complications.


The metal-on-metal contact may cause complications because it leads to the release of metal particles in the patient’s surrounding tissue, thereby increasing the cobalt-chromium metal toxicity in the patient’s blood, tissue and organs.  The metal particles may give rise a condition known as metallosis, which occurs when metallic fragments build up in the soft tissues that surround the artificial hip.  Over time, the patient’s tissue and organs breakdown and cause the device to fail.


DePuy Orthopaedics obtained approval for the DePuy Pinnacle artificial hip without conducting rigorous pre-market approval testing. It was approved under the 510(k) approval process as a “substantial equivalent” to older hip replacement devices, and it appears that a growing number of patients who had the hip implanted are discovering that it may be prone to early failure.


Many medical experts believe laying aside the necessary pre-marketing approval test may had been the main reason for the high failure rate of the Pinnacle. While the proposed average lifespan of a hip replacement should about 20 to 30 years, reports indicate that the Pinnacle has been known to fail in as little as five. In February 2011 the FDA warned of the risks of metal-on-metal hips, like the DePuy Pinnacle.


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