Several different types of metal-on-metal hip implants have been recalled and have come under fire in recent medical research. In July 2012, for instance, Stryker Orthopaedics announced the recall of its Rejuvenate Modular and ABG II modular-neck hip stem implant devices.
The U.S. Food and Drug Administration (FDA) has warned of premature failure of all-metal hips, which consist of a ball, stem and shell made from cobalt-chromium-molybdenum alloys.
When the moving parts of the artificial hip’s metal ball-and-socket joint rub together, metal fibers may flake off, according to the FDA. This can damage and destroy tissue surrounding the joint. It may also cause metal ions to enter the bloodstream and cause additional illness. Due to these side effects, all-metal hip implant patients may need extensive medical treatment, including surgery to remove the defective device.
If you believe that you or a loved one has been injured by a metal-on-metal artificial hip, Salvi, Schostok & Pritchard P.C. can help you. Call us today toll free or contact us online. We can provide a free, no-obligation consultation.
Metal-On-Metal Hip Implant Failures
The FDA first indicated concern about metal-on-metal hip implants in May 2011. The agency asked manufacturers to conduct postmarket surveillance studies of the devices. The FDA wanted to learn more about metal ion concentrations in the bloodstream of implant recipients.
Prior to FDA action, data had emerged among international orthopedic implant registries and various professional/scientific organizations. The data indicated serious complications and potential problems arising from the early failure of metal-on-metal (MoM) hip systems.
In April 2010, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) recommended blood tests and imaging for patients who had received all-metal hip implants and were experiencing abnormal pain.
In addition to the U.K. registry’s warning, Health Canada and the Therapeutic Goods Administration of Australia each published alerts in 2012 about MoM hip implants’ shedding metal flakes and/or chromium ions.
Finally, in a January 2013 Safety Communication, the FDA warned that metal can be released from the contact of the metal-on-metal joints in an artificial hip. Tiny metal particles that wear off from the device around the implant may cause damage to bone and/or soft tissue surrounding the implant and joint, the agency said.
This side effect, called metallosis, can cause pain, implant loosening, device failure and the need for surgery to replace the implant, the FDA said. Metal ions that enter the bloodstream can cause damage in other parts of the body as well.
All-Metal Hip Implant Recalls
Prior to FDA action, even the manufacturers of metal-on-metal hip implants acknowledged problems:
- In July 2008, Zimmer, Inc. recalled the Zimmer Durom Acetabular Component (“Durom Cup”), saying instructions to surgeons about how to implant the device were inadequate.
- In August 2010, DePuy Orthopaedics (a subsidiary of Johnson & Johnson) recalled its DePuy ASR TM total hip system because of the U.K.’s joint registry data that indicated the implants were failing prematurely.
- In June 2012, Smith & Nephew Orthopaedics withdrew the metal liner component within the R3 Acetabular System based on the U.K. and Australian oversight agencies’ data.
Additionally, Stryker recalled its Rejuvenate Modular and ABG II modular-neck hip stem implant devices due to what the manufacturer described as 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.
About 500,000 hip-implant patients in the U.S. have undergone corrective surgery because their metal-on-metal hip implants have failed prematurely, according to a January 2013 report in the New York Times. The newspaper said problems with metal-on-metal hip implant systems represented “one of the biggest [medical] device-related failures in decades.”
Legal Help For Illinois Metal-on-Metal Hip Implant Failure Victims
If you have had surgery to remove a metal-on-metal hip implant that failed prematurely, regardless of whether you were diagnosed with metallosis or another malady, you may have a legal right to seek compensation for your pain and suffering and your medical expenses.
Patients injured by defective medical devices, such as all-metal hip implants, can typically seek legal relief through product liability lawsuits. The manufacturers of defective medical devices may be liable based on:
- Designing and producing an inherently flawed device
- Inadequately testing the device for safety and effectiveness
- Improperly marketing the device for unapproved, or “off-label,” uses
- Failing to warn patients and surgeons about the risks, complications and side effects the device was known to cause.
Hip implant patients can pursue lawsuits in state or federal court. Because these cases often involve patients and families from around the country, they may be combined into a class-action lawsuit. They also may be consolidated into “multidistrict litigation,” or MDL, cases to speed up pretrial proceedings.
Regardless of how many patients are involved in a lawsuit, your attorney in a defective medical device case must ensure your rights and interests are protected at each step of the case. This requires an attorney experienced in large and complicated product liability claims.
If you have been injured by a faulty metal-on-metal hip implant, you should take action now to protect your rights.
Contact Our Chicago Defective Metal-On-Metal Implant Lawyers
If you believe that you were injured or lost a loved one due to an all-metal hip implant, contact Salvi, Schostok & Pritchard P.C. today. Our firm has obtained more than $650 million for our clients, including more than 195 multimillion-dollar verdicts and settlements. We can go to work on securing relief for you and your family.
Call us at today toll free for a free, no-obligation consultation or fill out our online form.