We are currently representing clients on potential products cases which involve two different types of metal on metal hips manufactured by DePuy, a subsidiary of Johnson & Johnson. The ASR model acetabulum, or cup, has been recalled and the Pinnacle metal on metal hip also demonstrates similar problems of early failure and development of elevated heavy metals, called metallosis. We are investigating potential claims for clients who are having problems with either of these two metal on metal hips by DePuy.
ASR Hip Replacement Recall Background
In August 2010, DePuy Orthopaedics issued a voluntary recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System. These products were first available in July 2003. Any hip surgery performed prior to this date is not subject to a recall.
These recalled products are constructed entirely of metal. The metal-on-metal construction may result in metal debris flaking off and damaging the surrounding tissue. The presence of this metal may also cause increased cobalt or chromium levels in the joint, the kidneys and in the blood system. Elevations of these elements are known to cause cancer in both humans and animals and they can cause a variety of medical problems.
1. What should I do if I’ve had a total hip replacement surgery since July 2003?
You should contact your doctor and find out whether your artificial hip was manufactured by DePuy, and, if so, if it is the kind that has been recalled. This information will be in your medical records, and your health care provider will let you know. It is wise to obtain copies of these medical records to confirm which implants you have and meet with an attorney to discuss your options. When you request this information also be aware that the important question to be answered is the model name of the specific acetabulum or cup and femoral component. A variety of different types of stems, including but not limited to Summit or Corail stems as examples, have been used with the ASR cup.
2. What symptoms should I be concerned about?
Some symptoms that may indicate a problem include unexplained hip pain, difficulty walking, swelling or inflammation of the tissue surrounding the implant, or loosening or fracturing of the hip.
3. So what happens if my artificial hip is the DePuy product that was recalled?
If you do have the recalled DePuy hip, schedule an appointment with your doctor. Your doctor will want to examine you to determine if the implant is functioning properly. Some patients, the majority, in fact, seem to do well no matter what kind of artificial hip was used. You may need to have another surgery using a different artificial hip. Your doctor will probably want to continue to monitor you over time.
4. What kind of monitoring will my doctor do?
Your doctor may evaluate the level of cobalt and chromium ion levels in your blood or urine, as well as perform x-rays, an MRI, or ultrasound scan. He may wish to draw some synovial fluid from your hip to determine if it has evidence of metal debris. If cobalt or chromium levels in your blood or urine exceed a predetermined amount, a second test may be scheduled three months after the first. If the other tests reveal soft tissue reactions, fluid collections, or tissue masses, your doctor may suggest a second surgery to replace the socket or cup portion of the hip, the acetabulum, if not the whole unit. A normal x-ray may not rule out significant problems with this device so further testing is generally warranted.
5. I received a letter from DePuy asking me to sign a form allowing the release of my medical records to “service providers” – what should I do?
Do not sign this release form. You don’t want your medical information or your artificial hip itself to be available to all different people and companies. In the wrong hands, your medical information may very well be used against you at some point. DePuy wants to lead you down a path to settle for the least amount of money possible. Don’t sign the form!
6. How many artificial hips has DePuy recalled?
The company has recalled 93,000 defective hips.
7. Why is this product being recalled?
DePuy has acknowledged that the metal-on-metal hip replacement system may fail within a few years after the surgery. Hip implants typically last 15 years or longer.
These devices have an increased risk of problems. Research by various medical groups in Britain have determined these are failing within the first 60 months at rates any where from 12% to nearly 60% of the time. Fractured bones around the implant or dislocations are also possible. Additionally, with the metal-on-metal construction, it is possible that cobalt and chromium could flake off and get into your blood, kidneys, bones, and tissue. Elevations of these metals may cause a number of medical problems, including cancer. It appears that patients with pre-existing kidney problems may be at somewhat higher risk.
What if your hip is a metal on metal Pinnacle hip, not an ASR hip by DePuy?
The metal on metal Pinnacle hips manufactured by DePuy also appear to be failing at a higher rate than expected and these patients have similar problems with elevations of chromium and cobalt and require more early revision of their hips.
While these hips have not yet been recalled, there are hundreds of reports to the FDA indicating problems with the devices and there is a possibility they will be recalled in the future.
Given the widespread difficulties so many patients have experienced, you may wish to speak with an attorney about your Pinnacle hip if you are having increased pain, or such problems as dislocation. You may want to consult with your physician and have the same sort of monitoring described above, including blood tests for elevations of the heavy metals, cobalt and chromium, and such studies as x-rays, ultrasound and MRI. Again, a normal x-ray may not rule out a significant problem.
New literature is just coming out which shows the seriousness of health problems that can result from these metal on metal hips:
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