I had a hip replacement a couple years ago. I have had some problems with it. Now I have received a letter from DePuy Orthopaedics, which has something to do with Johnson & Johnson, saying that my hip is being recalled. What should I do now?
A total hip replacement replaces the body’s natural joint with an artificial one, usually made out of metal and plastic. A typical total hip replacement system consists of four separate components: (1) a femoral stem (2) a femoral head, (3) a liner, and (4) an acetabular shell. The surgeon hollows out a patient’s femur bone and the femoral stem is implanted. The femoral head is a metal ball that is fixed on top of the femoral stem. The femoral head forms the hip joint when it is placed inside the polyethylene liner and acetabular shell.
The DePuy ASR artificial hip replacement system. The first components of the system was approved for use by the FDA in late 2003. Other components or related systems were approved for use in later years.
On March 8, 2010, Pamela L. Plouhar, Vice President of Worldwide Clinical Affairs for DePuy, issued an “URGENT FIELD SAFETY NOTICE” to surgeons concerning a high amount of revisions of people who received the ASR prosthesis. On or about July 17, 2010, a Class 2 recall of many of the ASR components was posted on the FDA’s website and both the DePuy ASR XL Acetabular and DePuy ASR Hip Resurfacing Systems were recalled. It appears that there are some 27,000 people in the United States who have replacement hips that are the subject of the recall. The company has said that only the DePuy ASR XL Acetabular system was used in the United States.
The symptoms of the problem include pain, swelling and problems walking. Continuing symptoms may indicate that the implant is not staying attached to the bone in the correct position, has been fractured, or has been dislocated. Another problem is the release of metal particles into the joint and in the muscles around the joint. In some patients this can result in pain and swelling and could cause damage to the muscles, bones and nerves around the hip. Tests are necessary to determine if the hip is working properly and if there is a reaction to the metal particles.
This recall means additional testing and treatment may be necessary to ensure your hip implant is functioning well. DePuy intends to cover reasonable and customary costs of testing and treatment, including revision surgery if it is necessary, associated with the ASR recall. Even if you do not have out-of-pocket medical expenses, please contact the DePuy ASR Help Line so that you may be assigned a claim number. This will allow DePuy to process other reasonable out-of-pocket costs, such as lost work time and travel expenses, which may be reimbursed. These costs will be more clearly defined shortly and are subject to review on a case-by-case basis.
In plain English, this means DePuy may pay lost work time and travel expenses but apparently is refusing to pay other damages associated with this product failure, such a pain, suffering, disfigurement, or disability associated with yet another hip surgery and recovery. I haven’t seen your letter, but the website doesn’t mention that there is a deadline for filing suit under Tennessee law (and the law of other states as well). Under Tennessee law, the failure to file suit within one year will result in a loss of rights and DePuy will be legally obligated to pay nothing to Tennessee residents who were harmed by the device.
I suggest that you contact a lawyer to help you understand what your options are under Tennessee law. We are filing a lawsuit against DePuy on Monday October 4 concerning these hip replacement systems.