What is the DePuy Hip Replacement Recall?
The market withdrawal of the DePuy ASR hip replacement system earlier this year, combined with a warning to physicians about the high failure rate associated with the device, are now being called a DePuy ASR recall by the FDA.
The FDA indicated that the actions of DePuy Orthopaedics,in regards to its ASR hip implant, were classified as a Class 2 medical implant recall. Specifically, the company’s notification to clinicians of new revision rate information regarding the use of the devices was cited as a reason for the DePuy ASR hip recall.
The manufacturer initially indicated that their decision to remove the device from the market was not issued due to any safety problems with DePuy ASR hip cups, rather because of low sales numbers. However, on March 6, DePuy sent a letter to doctors indicating that the ASR hip implant has been linked to a high failure rate. Many patients who received DePuy ASR hip replacements have experienced hip failures soon after the device was implanted, leading to additional hip surgeries.
The DePuy hip recall involves 29 models of the ASR 100 and 300 Acetabular Implants in cup sizes ranging from 44mm to 70 mm.
The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. Health care professionals have increasingly been warning about problems with metal-on-metal hip implants, which can shed metal particles into the body. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.
Between 2007 and 2009, reports of problems with the DePuy ASR hip began to spike, with nearly 100 recipients reporting problems in 2007, more than 200 reporting problems in 2008, and more than 300 reporting problems in 2009. Last year, U.K. researchers studied 660 patients who had received metal hip implants from DePuy Orthopaedics and found that 3.4 percent suffered from adverse reactions to metal debris. Surgeons are warning that one to three percent of all metal on metal hip implant recipients may experience hip implant problems, and possibly need to have the devices replaced, due to metallic debris.
In recent months, a number of DePuy hip lawsuits over faulty ASR Cup implants have been filed. It is expected that the number of cases will continue to grow as Depuy ASR recall lawyers continue to investigate and review potential cases for individuals who have experienced problems and complications after hip replacement surgery involving the device.
Why the recall?
Each of these metal units replaces a worn or weakened part of the natural hip (which consists of a socket and a rounded bone that fits into that socket like a ball). Total hip replacement involves replacing both parts at once. The defective replacement hip units have been recalled because one in eight patients requires a second invasive procedure to correct the first one. The replacement hips just don’t fit the way they’re supposed to. Many orthopedic doctors believe that the units were poorly designed.
Both the Acetabular System and the Hip Resurfacing System became available in July 2003. Therefore, if you had hip replacement surgery only prior to this date, then you are not subject to this recall. If you had hip replacement surgery after July 2003, however, there is a possibility that you received a defective, dangerous ASR device.
The only way to find out for sure is to speak with your doctor. It is possible that you were implanted with a recalled ASR device but will not require additional surgery. Your doctor can perform an evaluation and let you know if you have developed or are at risk of developing dangerous health problems. J&J/DePuy recommend that you undergo this checkup even if you are not experiencing any symptoms.
If you are among the twelve percent of ASR recipients who require revision surgery, chances are you have experienced painful side effects such as:
- Hip pain
- Thigh or groin pain
- Pain while walking
- Pain when rising from a seated position
- Pain bearing weight
- Swelling
J&J has stated that it is “committed to assisting patients… and paying for the cost of doctor visits, tests and procedures associated with the recall.”
Our lawyers will demand compensation for you promptly and efficiently.
The first thing you should do is speak with your doctor. You might not know what hip replacement device(s) you received. Johnson & Johnson itself does not keep records of this information. Only your doctor (or the hospital where your surgery took place) can confirm whether you have an ASR unit.
It is possible that you will learn that your replacement hip is indeed an ASR unit. Yet you might not be experiencing any symptoms, such as hip, thigh, or groin pain, or pain while walking, rising from a seated position, or bearing weight. Even if you have not been noticeably injured by an ASR unit, it is possible that your replacement hip is faulty. You could develop painful side effects in the future.
What to expect at your doctor’s visit
During your doctor’s visit, you can expect to have a blood test to measure the level of microscopic metal parts surrounding your hip, in addition to other testing to determine if your hip replacement if functioning properly. Only by receiving a complete medical diagnosis can you can be sure that you are not in danger. Depending on what your doctor recommends, this could include returning for an annual evaluation to make sure the ASR device inside of you continues to function safely.
If your doctor determines that your ASR device(s) should be removed and replaced, your next step should be to contact our lawyers.
1 in 8 Patients Currently With The Implants Need Revision Surgery
Approximately 400 US patient complaints related to the XL Acetabular System have been submitted to the FDA.
Using the generally accepted standards for this product type, no more than 1 in 20 patients should have a revision within five years. Data shows that five years after implantation, about 12% of patients who had received the ASR™ resurfacing device and 13% of patients who had received the ASR™ total hip replacement needed a second surgery. Revision surgeries are usually technically more difficult, may take longer and the recovery is more prolonged.
Compensation For Patients
If you have received an ASR™ Hip Resurfacing System or ASR™ XL Acetabular System and have experienced symptoms related to your DePuy system, you may be entitled to compensation.