In the fall of 2010, a recall was implemented for the DePuy ASR hip replacement system, causing the public to question DePuy’s reliability as the leading medical device manufacturer in the world. DePuy is a subsidiary of Johnson & Johnson. When the recall was initiated, the failure rate of the ASR system was estimated to be 12-13% among patients. DePuy has another hip replacement system called the Pinnacle which is similar to the recalled ASR model.
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. The 510(k) approval process allows a medical device to be placed on the market without being subjected to necessary clinical trials. The ASR system is a metal-on-metal hip replacement device that utilizes a metal ball and metal lined cup to replicate the natural movement of a hip joint. Some Pinnacle hips are also metal-on-metal because the device can include a metal liner. DePuy claimed that metal-on-metal hip replacements have increased durability.
The most prevalent and serious problem associated with metal-on-metal hips is metallosis, which can lead to soft-tissue damage, rashes and pseudo-tumors. Another common complaint of the DePuy Pinnacle hip replacement system is loosening of the device. One of the more serious complications is bacterial infection, occurring more often in elderly or obese patients. In addition, blood clot formation is another life-threatening condition, especially if the clot travels through the bloodstream and causes a stroke.
Although a DePuy Pinnacle hip recall has not been issued, patients who have been implanted with the DePuy Pinnacle Acetabular Cup System may have legal recourse. Several DePuy Pinnacle lawsuits have already been filed, and patients experiencing DePuy Pinnacle problems with the metal-on-metal systems may be able to participate in a similar legal action. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.
