DePuy Hip Recall Spurred by High Failure Rate.
Johnson & Johnson subsidiary DePuy Orthopaedics began marketing its metal-on-metal hip replacement system in 2005. The FDA granted a special clearance for the ASR XL Acetabular System before any clinical trials were performed to determine the product’s safety. After receiving several hundred complaints about the unit between 2008 and 2010, DePuy began warning patients and doctors about the abnormally high rate of failure. Nearly one in eight recipients experienced any of a variety of problems requiring what DePuy called “revision surgery.” With such a high percentage of patients having to undergo a second surgery, a DePuy hip recall was likely.
Numerous Maladies Associated with DePuy Hip Recall.
The DePuy hip replacement system has undergone much criticism for failing components. The hip replacement unit has been said to become loosened and improperly aligned, which can cause infected hip joints, metal sensitivity, fractured or dislocated bones, and chronic pain. Other issues which may have contributed to the DePuy hip recall included bone staining, necrosis and increased metal ion blood levels. Damage also may occur to nerves, muscles and tissues. Even the revision surgery to remove the DePuy hip can be dangerous—complications have been cited in patients due to small fragments of the original unit left behind in the joint.
Official DePuy Hip Recall — August, 2010.
After months of adverse DePuy hip replacement reports, DePuy finally announced a recall of their ASR XL hip replacement system on August 24, 2010. The five-year failure rate was determined to be 13 percent, based on data gathered from an implant registry in Australia. Prior to the recall, DePuy claimed to be phasing out the unit due to a lack of sales. Parent-company Johnson & Johnson had endured recall problems earlier in 2010. Three years prior, DePuy was involved in a scandal involving payoffs to doctors.
After the DePuy hip recall, the first DePuy hip lawsuit was filed. With over 93,000 units in use, and a thirteen percent failure rate for such devices, Johnson and Johnson may easily see several thousand lawsuits filed. For these lawsuits, a DePuy hip lawyer will likely claim that DePuy knew the design of its devices was flawed and did not correct it after they became aware of the problem. The lawsuits will likely also claim that DePuy failed to notify or warn doctors or patients of the potential problems.
If you or a loved one has suffered an injury that may be related to the use of the DePuy hip replacement system, you should contact Chaffin Luhana LLP immediately for a free and confidential case review today. You may be entitled to compensation, and the lawyers at Chaffin Luhana can help. Call our toll free number today for a free, no-obligation case evaluation: 1-888-480-1123.