Metal-on-metal hip implants have been found to fail prematurely and cause a condition known as metallosis as they shed flakes of metal into the patient’s body. Government oversight agencies around the world, as well as researchers and medical professionals’ groups, have warned surgeons and patients about the use of all-metal hip implants.
At least four metal-on-metal hip manufacturers have issued voluntary recalls of their products:
Stryker Orthopaedics announced in July 2012 that it was recalling its Rejuvenate Modular and ABG II modular-neck hip stem implant devices. In its recall notice, Stryker said the artificial hip systems pose a risk of fretting (wearing down and flaking of metal parts) and/or corrosion at or about the modular-neck junction.
Stryker also said information about fretting / corrosion problems collected since the devices entered the market might indicate that the frequency of these problems constituted a trend.
Smith & Nephew recalled the metal liner component within its R3 Acetabular System in June 2012 because of a higher-than-expected number of revision surgeries associated with the use of the device in total hip replacements outside the U.S. The company cited data from the Australian and United Kingdom’s implant registries indicating premature device failures.
The Australian Orthopaedic Association’s National Joint Replacement Registry found that 5 percent of the metal liners used in the R3 Acetabular System had to be replaced after about two years. More than 6 percent failed within four years, according to the UK’s National Joint Registry.
A majority of Smith & Nephew’s recalled metal prosthetic hip components were used in stemmed total hip replacement procedures, the company said. The optional metal liner component within the R3 Acetabular System received FDA premarket approval in November 2008 for use with the firm’s BHR Hip resurfacing head. It was first used in Europe and Australia in 2007 and launched globally in 2009.
DePuy Orthopaedics, a subsidiary of Johnson & Johnson Medical Devices and Diagnostics, issued a voluntary recall of its ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System in August 2010. The recall was based on data from the U.K.’s joint registry indicating that about 13 percent of implant recipients receiving the DePuy ASR total hip system required revision surgery within five years.
The ASR XL Acetabular Hip System first became commercially available in the U.S. in December 2005, DePuy said. The ASR Hip Resurfacing System was not commercially available in the country. Approximately 93,000 patients worldwide received DePuy ASR hip implants, the company said.
The ASR XL Acetabular System was approved for use in the U.S. through the FDA’s 510(k) approval process, which does not require evidence from clinical testing of a medical product.
Zimmer Inc. recalled its Zimmer Durom Acetabular Component (“Durom Cup”) in July 2008, saying its instructions to surgeons were incomplete.
The Durom Cup is a one-piece metal socket device with a plasma coating. The plasma coating was to stimulate the growth of bone tissue, making the prosthetic joint more stable. Too often, though, the implant did not attach to the existing bone as expected. Implants that failed became loose and had to be replaced.
If you recognize one of these recalled metal-on-metal hip implants as one that you received, you should consult your physician without delay. If you have unexpected pain from an all-metal hip implant and are unsure of the product you received, you should contact your doctor to get more information about the product.
You can also contact a lawyer to help you find out information about your implant. An attorney can help you to secure any compensation you are entitled to receive due to your injuries and losses.
There may be deadlines for filing a lawsuit in your case. If you believe you have been hurt by a faulty metal-on-metal hip implant, it is important to take action now to protect your rights.
Call Salvi, Schostok & Pritchard P.C., today at our toll-free number for a no-charge, no-obligation consultation. You can also schedule a review of your case through our online form.