Hip & Knee Replacements FAQWhy are hip and knee implant devices being recalled?
Some hip and knee implant devices are being recalled because of high failure rates that result in patients requiring revision surgery years before they typically should. For example, most hip implants are expected to last approximately 15 years, but with some implant devices, such as the DePuy ASR hip replacement devices, some patients are undergoing revision surgery within five years of initial implantation.
Although information on this page includes the DePuy Pinnacle hip replacement device and the Zimmer NexGen CR-Flex Knee Replacement, neither of these devices has been recalled.
What companies are involved in hip and knee replacement recalls?
Companies involved in manufacturing hip and/or knee replacement devices that are under scrutiny include:
- DePuy Orthopaedics, maker of the DePuy ASR XL Acetabular System and the ASR Hip Resurfacing System (both of which have been recalled) and the DePuy Pinnacle (which has not been recalled).
- Zimmer Holdings Inc., maker of the Zimmer Durom Acetabular Component (sales of the cup have been suspended) and the Zimmer NexGen CR-Flex Knee Replacement (which has not been recalled);
- Stryker Corp., maker of the Trident Acetabular PSL Cup and the Trident Hemispherical Cup, both of which were recalled in 2008.
Some companies currently face lawsuits linked to their joint replacement devices. Those include DePuy Orthopaedics and Zimmer Holdings.
What do these lawsuits allege?
The lawsuits allege that the makers of the devices either knew or should have known about the high failure rates associated with their implant devices but failed to adequately warn patients. Furthermore, they allege that failure of the devices resulted in pain and often required revision surgery, which came with its own risk of complications.
Why are there concerns about revision surgery?
Revision surgery is not as simple as taking out one implant device and putting in another. With each revision surgery, the procedure becomes more complicated, increasing the risks associated with the surgery and, potentially, requiring a longer recovery time. Longer recovery times can affect a person's income and can result in higher medical bills and rehabilitation costs.
Why are there problems with newer hip replacement devices?
Some newer devices, such as hip replacement devices were made with a metal-on-metal design, in which both the ball and the socket of the implant device are made of metal, such as cobalt and chromium. The metal-on-metal design was thought to be more durable and longer lasting than traditional hip implant devices, making them ideal for younger patients who required hip replacement surgery.
Unfortunately, regular wear and tear of the metal-on-metal devices has been linked to metallic debris coming loose from the hip implants and being absorbed by the patient's surrounding tissue, resulting in pain, tissue death and bone problems. Furthermore, this condition can result in failure of the hip implant device. Because failure of these metal-on-metal hip replacement devices is linked to damage of the surrounding soft tissue, revision surgery to replace the hip implant can have serious complications.
The metal debris may be caused by poor design or by problems with implantation of the device. Critics of metal-on-metal hip replacements, however, say that implantation issues do not cause such serious problems for patients who receive hip implants that are not metal-on-metal.
What is hip implant metallosis?
Metallosis is a condition in which metal debris is absorbed by tissue, resulting in high levels of metals, such as cobalt and chromium, in the system. It can result in pain, inflammation, tissue death and bone destruction.
What are some symptoms that my implant may be failing?
Symptoms of a potential hip or knee implant failure include pain in the area, reduced or restricted movement, pain when moving, difficulty walking, and popping or crunching sensations in the joint.
What should I do if I have one of the recalled devices implanted?
If you have one of the recalled devices, such as the DePuy ASR XL Acetabular System, speak with your doctor about your options. You may be required to undergo medical testing to ensure levels of cobalt and chromium in your system are within the normal ranges.
If you have a hip or knee implant device and feel any unexplained or unusual pain in the surrounding area, speak with a doctor, who can determine if the hip or knee implant is failing.
When should I contact an attorney about my implanted device?
If you have a recalled hip or knee implant device, contact an attorney to discuss your options, even if that device has not yet failed.
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Last updated on Jun-1-11