subject: Early Failures Might Lead to DePuy Pinnacle Recall [print this page] Early Failures Might Lead to DePuy Pinnacle Recall
In the typical hip replacement surgery, the upper end of the thighbone is replaced with a metal ball and the hip socket is resurfaced with a metal shell and plastic liner. The replacement joint may now be fused to bones with or without cement, and as more innovative techniques are discovered, the process becomes less and less invasive. Unfortunately, as new products are brought to market, it is sometimes not possible to tell the ones that will be durable and provide the recipient with long lasting use of a new hip from the ones that will fail after just a few years.
One of the root causes of this issue is that the process by which many medical devices are approved by the U.S. Food and Drug Administration (FDA) does not involve pre-market testing. The "Section 510(k)" approval process authorizes companies to sell medical devices based solely on the "substantial similarity" of the device to other, already approved devices.
One such device is the DePuy ASR hip replacement system. In 2010, the wave of failures of the system finally reached a critical mass and a recall was issued. The FDA had originally approved the DePuy ASR system through the 510(k) process for its substantial similarity to another of DePuy's productsthe Pinnacle hip replacement system.
Although there has been no indication that there will be a DePuy Pinnacle recall, it is something to keep an eye on. This is especially true because there have been some rumblings regarding the viability of the Pinnacle system. The FDA has received more than 500 negative reports about the product since 2003, most of which indicate that the product is loosening, causing severe pain in the patient and in some cases even requiring revision surgery. Once the product loosens, life becomes very hard for the patient, as simple tasks such as sitting up and straightening the legs become extremely painful.
One person has already filed a Pinnacle lawsuit against DePuy, in United States District Court in California. The plaintiff apparently suffered loosening of the device and has suffered serious pain, resulting in a constant limp. Even if the problem can be fixed through further surgery, she will have to spend time after surgery recovering. The last thing anyone who recently went through a serious operation wants to deal with is more surgery.
If you have suffered loosening or abnormal pain, or required revision surgery to fix or replace your DePuy Pinnacle hip system, you might have a claim against the device's manufacturer. The first step in determining if you do is to speak to a legal professional with experience handling this type of problem. The Rottenstein Law Group's attorneys have represented their clients' interests against big companies for over 25 years.
