Risks Associated With DePuy Pinnacle Hip Replacements Should Be Understood By Patients
Last fall 2010, a recall was initiated for the DePuy ASR hip replacement system, making the public question DePuy’s reputation as a dominant figure in medical device manufacturing. When the recall was first implemented, the failure rate of the ASR system was reported to be 12-13% among those receiving the device.That is equivalent to one out of every eight patients that need to undergo corrective surgery just five years after their initial hip replacement procedure. This has set the stage for potential DePuy Pinnacle lawsuits that the company will have to face.
The U.S. Food and Drug Administration (FDA) allowed the marketing of the DePuy ASR system to the public through the 510(k) approval process on the basis that the device was substantially equivalent to the DePuy Pinnacle hip replacement system already approved for distribution. Both the ASR and Pinnacle systems are metal-on-metal hip replacement devices that utilize a metal ball and metal lined cup to replicate the natural movement of a hip joint.In contrast to a typical hip replacement system that utilizes a synthetic plastic liner inside the socket part of the synthetic joint, metal-on-metal devices are typically more durable.
All patients expect that the hip replacement system used in their hip replacement has undergone rigorous testing before being put on the market. However, the FDA’s 510(k) approval process allows a medical device to be placed on the market without being subjected to necessary clinical trials. Once these devices are placed on the market, the public will appreciate how detrimental this approval process is.
While the most common concern attributed to the DePuy Pinnacle system is premature loosening, there are problems associated with this device that are more severe, yet very rare. The most serious of these complications is sepsis from bacterial infection, which occurs more often in elderly or obese patients. More life-threatening is the possibility of blood clot formation, which could travel through the bloodstream and cause cardiovascular damage. Patients receiving metal-on-metal hip replacement systems should be aware of these signs of possible metal toxicity and should consult with a doctor at the first indication for confirmation of a diagnosis
It is important for recipients of the DePuy Pinnacle system to know the risks associated with the device such as hip pain, loosening or detachment of the device and metal toxicity. Patients experiencing these symptoms may have the basis of a lawsuit and should consult with an attorney. Visit the DePuy Pinnacle lawsuit website for more information.