Recalled: The DePuy ASR Metal on Metal Hip Replacement System
What is the DePuy ASR metal hip replacement system?
The DePuy ASR is a total hip replacement system, where your existing hip joint is removed and replaced with an artificial ball and socket system designed to mimic a natural hip joint. A metal socket is placed in the pelvis where the original hip socket was, and the femur is implanted with a ball attached to a stem. In most current hip replacement products, the lining of the socket is made of plastic or ceramic. The ball is usually made of metal or ceramic. There is some wearing down of the lining that is expected to occur over many years as with the friction of the joint moving with these “metal on poly (plastic) or ceramic” joints. In nature, your hip has cartilage to perform this function.1 However, a new product of “metal on metal” where BOTH the ball AND socket were metal was marketed and implanted in thousands of patients. This was called the DePuy ASR system.
Does it work?
On August 24, 2010, the DePuy ASR™ was voluntarily recalled by DePuy Orthopaedics, a division of Johnson & Johnson.2
In the case of a voluntary recall, this does not mean that your implant will fail. You should contact your physician to confirm that you did, in fact, receive this implant, and discuss any questions you may have concerning your surgery.3
Patients who had hip surgery prior to August 2005 are not affected by the recall of this product. The DePuy ASR was used in hip replacement surgery from August 2005 to August 2010.
The DePuy ASR™ XL Acetabular System was available worldwide.
Information was provided from a New Zealand study that showed complications occurring in 13% of patients receiving this implant.4
While some patients have experienced the expected benefits of this type of implant, you are cautioned to have regular checks-ups, blood tests to detect metals in your blood since these may be dangerously elevated in your blood as a result of “metal on metal wear”, and report any problems to your doctor immediately.
DePuy Orthopaedics, the manufacturer of the DePuy ASR, also recommends that your device be evaluated by your physician.5
Side effects reported by patients using this product…
Because of the unique metal on metal design, friction between the femoral head and socket, causing particles of the implant to detach and enter the bloodstream has been reported. If the friction is adequate, the buildup of metal ions in the bloodstream can cause metallosis, heavy metal poisoning, metal sensitivity, bone weakening and tissue destruction.6 The design may also cause the joint to become unseated or “slip” out of the socket.
An implant that has been poorly designed will restrict the flow of synovial fluid (the fluid in your joint) between the parts of the hip implant, thus increasing the amount of friction, pain and discomfort experienced by the patient.
Patients have also experienced pain in the groin, hip or leg, swelling at or near the hip joint, as well as a limp or change in walking ability.
The manufacturer of this device can be held responsible for any damages that you suffer as a result of obtaining this implant. Manipulation of the data used to gain FDA clearance may have occurred to under-report various complications. In some countries in Europe years before the FDA warning, there was advice that these problems were occurring and the product should not be implanted. You should consult an orthopedic surgeon about your original surgery and the status of your hip. Preferably , this should not be a surgeon who is a consultant for the manufacturer. You may also wish to obtain independent legal advice before you contact the manufacturer.
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1 http://www.moriarty.com/depuy_hip_recall/Stay_Informed/How_the_ASR_XL_Acetabular_System_is_Constructed/2 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241770.htm
3 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241770.htm
4 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241770.htm
5 http://asrrecall.depuy.com/usprofessional-depuy-hip-recall
6 http://www.moriarty.com/depuy_hip_recall/Stay_Informed/How_the_ASR_XL_Acetabular_System_is_Constructed/