Pinnacle Recall Now Looking Likely

Pinnacle Recall Now Looking Likely

Pinnacle Recall Now Looking Likely

Medical device implant surgeries become less and less invasive as more advanced techniques and products are continually developed. Hip replacement surgery is a perfect example of this. Most hip replacement surgeries today involve replacing the upper end of the thighbone with a metal ball and resurfacing the hip socket with a synthetic liner and the device may be fused to the bone with or without cement. The system is not foolproof, however, as from time to time a medical device hits the market that is dangerous or otherwise causes problems in the implant's recipient.

The U.S. Food and Drug Administration (FDA) can only do so much to balance allowing innovation in the medical device industry and keeping consumers safe. One way the FDA tries to maintain this balance is through the Section 510(k) approval process, whereby a product will be approved, without clinical testing, if it is "substantially similar" to another approved product.

One example is the DePuy ASR hip replacement system. The ASR was found to fail to bond properly to the bone, which caused the implant to loosen in patients. As a result, DePuy had to issue a recall of the ASR system and will likely have to fend off multiple court cases regarding the problem with the device. Another bit of interesting information stemming from the recall is that the device was approved through the Section 510(k) process for its substantial similarity to the Pinnacle hip replacement system, another DePuy product.

This does not necessarily mean that there is an issue making the Pinnacle system defective, but there is other evidence that indicates there may be a problem in the future. According to the FDA, there have been over 500 complaints regarding the Pinnacle system, mostly that the product is prematurely loosening. Loosening of a hip replacement system is a particularly debilitating flaw as it causes severe pain in the sufferer in making the simplest of movements, such as standing up or straightening the legs. In fact, there is already one lawsuit in place alleging that the product loosened, causing a pain and an abnormal gait in the plaintiff. Because of the failure, she will have to go in for more surgery to fix the issue.

Situations like this are becoming more and more common with the Pinnacle system. Despite the fact there has yet to be any indication of an upcoming Pinnacle recall, if you have suffered pain or loosening from your Pinnacle implant you may have the basis for a claim. The attorneys at the Rottenstein Law Group are experts in defective medical implant litigation that can help you figure out what your next step should be.

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