On August 26, 2010 the DePuy Orthopaedics division of Johnson & Johnson, issued a recall for its two hip replacement products, the ASR XL Acetabular System and the ASR Hip Resurfacing System. Following two years of more than 400 documented complaints from patients and their surgeons, DePuy Orthopaedics pulled both ASR systems from Australia in 2009 but not until 2010 in the US. DePuy Orthopedics initially announced in March 2009 its plan to phase out sales of the ASR XL Acetabular System and the ASR Hip Resurfacing System worldwide, but not before the ASR had been implanted in thousands of patients.
A number of orthopedic doctors believe the DePuy metal on metal implant had a design flaw that made it difficult to implant properly, specifically that the component has a narrow window for proper implantation. The design of the cup on the ASR is more shallow than other devices, which is believed to be one of the implant’s main problems. The ASR XL Acetabular System is a hip socket used in traditional hip replacement. The ASR Hip Resurfacing System is a partial hip replacement that involves placing a metal cap on the ball of the femur, to preserve a greater amount of bone. Both of these systems are metal-to-metal bearing type hips replacement systems.
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According the FDA, it has received approximately 400 complaints that involve patients who had had the devices implanted starting in 2008. Approximately 12% – 13% of patients subsequently needed a second hip replacement procedure within five years of receiving the ASR implant, according to DePuy. In some cases, the DePuy ASR implant was documented to fail within the first 1-2 years of the implantation. DePuy said that it made the decision to withdraw the products because too many patients required a second hip replacement after the company’s implants had failed. When the DePuy hip implants fail, often the hip implant patients need additional costly and painful hip replacement “revision” surgeries to remove and replace the faulty implant.
Approximately 250,000 people in the US receive hip replacement implants each year, with about one-third of those receiving metal-on-metal implants. It has been documented that patients implanted with metal-on-metal bearing type hip replacement systems like the DePuy ASR have developed Aseptic Lymphocyte Dominated Vasculitis Associated Lesion (ALVAL). ALVAL is an adverse tissue reaction to metal particles and ions, and may be the result of a toxic reaction to metal wear debris in the area of the DePuy hip implant. It has been documented that metal-to-metal bearing type hip replacement systems like the DePuy ASR can generate large amounts of metal debris during normal wear and tear, which can negatively impact soft tissue and evolve into serious health issues for patients.
Concerned patients should request their surgery records from the hospital ‘s medical records department to find out if a DePuy ASR hip implant was used in their hip replacement surgery.
If you or a loved one have been injured as the result of a DePuy Orthopaedics – Johnson & Johnson hip replacement implant product, talk to a DePuy Hip Implant Attorney at the Willis Law Firm for legal advice about a potential DePuy hip replacement lawsuit. Please fill out the Free Case Evaluation at the right or call us toll-free at 1-800-883-9858.
IMPORTANT NOTE: If you are required to have a revision replacement surgery to remove and replace a faulty DePuy Hip Implant, notify your doctors that you want the hip implant to be preserved as evidence and NOT shipped or returned to the manufacturer, as it is critical evidence in a potential product liability lawsuit against DePuy and Johnson & Johnson.