The ASR is a hip replacement system that was initially approved by the FDA in 2005. The DePuy® implant was pulled off the shelves earlier this year due to high failure rates. The product is also listed .jpg)
on the FDA website as being the subject of a Class II recall/Field Safety Notice effective July 17, 2010. It was then recalled by the manufacturer on August 24, 2010. The DePuy® hip implant received 501(k) approval as being substantially similar to other devices already marketed. As the New York Times reported in March of 2010, this meant the DePuy® hip device was approved without undergoing the normally required clinical trials.
The DePuy ® hip system is a metal on metal ball-and-socket hip prosthesis used in hip replacement surgery. DePuy® touted the implant as a "high performance" replacement system claiming significant advantage over other more conventional implants or hip resurfacing. However, the ASR hip implant did not live up to DePuy®'s representations. In Fact, the FDA has received over 300 complaints from patients or their doctors about the DePuy® hip prosthesis since 2008. Reportedly, some experts believe that the metal on metal contact of the ASR creates metal debris that damages nearby muscle and soft tissue. Others are critical of the shallow ASR hip replacement cup. The New York Times March report mentions that several orthopedic experts back up this claim, stating that due to its design the ASR hip replacement system is harder to position in surgery.
Stephen Graves, MD, the director of the implant database in Australia, has been quoted as saying that the ASR implant fails much sooner than the supposed 15 year life span. In December of 2009, the ASR was taken off of the market in Australia after Dr. Graves's research was published. DePuy® then announced that the ASR hip implant would be phased out allegedly due to a decrease in sales. However, on March 6 of this year, DePuy® Orthopedics basically conceded the device had a higher than expected failure rates and pulled it from the market.
Premature failure of a hip implant can result in significant physical, emotional and financial hardships. Lawsuits against DePuy® are beginning to be filed around the country. These lawsuits assert that the DePuy® hip implant system was defective, and that DePuy® knew of the increased potential for failure.
If you have had a hip replacement since 2003 and are experiencing pain or were required to undergo another replacement check with your physician or hospital to determine if you had a DePuy® ASR hip implant used. If you or a loved one has been harmed by DePuy®'s delay to announce the problems with the ASR system, contact Perdue Kidd & Vickery for a free consultation and claims evaluation. You may be eligible to collect damage compensation.
