Metal-On-Metal Hip Implants & Metallosis

Worldwide Metal-on-Metal Hip Implant Recalls over Metal Poisoning Risks

Stryker has joined other manufacturers in removing certain metal-on-metal hip implants from the market after complaints over debilitating side effects, such as severe pain and toxic metal poisoning caused by debris eroding from the implants, known as metallosis.

Symptoms of metallosis may include:

  • Pain around the joints
  • Swelling around the affected area
  • Rash or redness around the affected area
  • Difficulty walking

Two Stryker implants – the Rejuvenate and the ABG II Modular-Neck Hip Stem systems – were voluntarily recalled in 2012 becoming the latest in a string of worldwide recalls over the last several years involving metal-on-metal hip implants.

Patients who have received the following metal-on-metal hip implants may be entitled to compensation:

Stryker

Models:

  • Rejuvenate
  • ABG II Modular-Neck Hip Stem

Biomet

Models:

  • M2a, which includes M2a-Magnum, M2a-38, M2a-Taper, M2a-28mm
  • Stanmore
  • Exceed ABT

DePuy Orthopaedics (Johnson & Johnson)

Models:

Smith & Nephew

Models:

Wright Medical

Models:

  • Conserve Plus Total Resurfacing Hip System
  • Profemur Z Hip Stem

Zimmer Holdings

Models:

The Facts: Stryker Metal-on-Metal Hip Implants

  • It wasn't long after the Food and Drug Administration (FDA) began approving metal-on-metal hip implants that FDA concerns surfaced. The FDA approved Stryker's Rejuvenate system in 2008, and the ABG II Modular-Neck Hip Stem system in 2009.
    Both systems were approved under a process that does not require evidence of a device's safety before being given market approval. Known as the FDA 510(k) Premarket Notification Process, manufacturers merely have to show that devices are substantially similar to others currently on the market.
    • In February 2011, the FDA issued a warning that metal-on-metal hip implants carried "unique risks" because of the risk of metal shavings seeping into nearby tissues and the blood stream.
    • In May 2011, the FDA ordered all manufacturers of metal-on-metal hip implants to test patients who had received the devices.
    • Subsequently in 2012, Stryker issued an "Urgent Safety Alert" to healthcare providers that outlined the potential hazards in its two hip implant systems (the Rejuvenate and ABG II Modular-Neck Hip Stem systems). These hazards included "excessive metal debris" and "increased metal ion generation in the surrounding joint space."
    • That same year, Stryker voluntarily recalled the Rejuvenate and ABG II Modular-Neck Hip Stem systems.
    • In a multi-district lawsuit in 2014 relating to defective metal hip replacements, Reuters reports that Biomet was ordered to pay at least $56 million by the federal court of Indiana (Biomet's headquarters).
    • According to Bloomberg, DePuy will pay more than $4 billion to resolve more than 7,500 lawsuits over its recalled hip implants. Some say the DePuy settlement is the largest U.S. settlement ever for a medical device.

Metal-on-Metal Hip Implant Side Effects and Metallosis

Metal-on-metal hip implants can shed metal particles into the surrounding tissue, enter the bloodstream, and may potentially lead to toxic metal poisoning. This metal poisoning, known as metallosis, is caused by the accumulation of tiny metal particles in the tissue, joints, and blood.

Symptoms of Metallosis

Symptoms of metallosis may include:

  • Pain around the joints
  • Swelling around the affected area
  • Rash or redness around the affected area
  • Difficulty walking

Metal-on-Metal Hip Implant Lawsuits

  • Damage or death of surrounding bone and tissue
  • Organ damage
  • Inflammation, leading to severe pain
  • Bone or tissue loss
  • Permanent disability
  • Cancer
  • Neurological and cardiac disorders

Patients who experience these side effects may have to undergo corrective surgery and have their implants replaced.

Other Damaging Side Effects of Metal-on-Metal Hip Implants

By the time Stryker recalled its two metal-on-metal hip implant systems, the FDA had already received more than 60 formal adverse event reports of metal toxicity requiring revision surgery. Many more complaints were lodged against the company alleging other side effects as a result of the hip implants.

Stryker put these implants on the market without having to show any testing that led to proof of their safety. Through the regulatory loophole known as the 510(k) Premarket Notification Process, Stryker was able to get approval for these devices simply by showing that they were "substantially similar" to a product already on the market.

The safety of these devices was not proven before they were sold to patients. And now thousands may have suffered serious side effects as a result of receiving these potentially dangerous devices.

North Carolina Lawyers Can Evaluate Your Hip Implant Claim – Free

If you received any of the metal-on-metal hip implants noted here and you believe you suffered serious side effects such as metallosis, you may be entitled to compensation for your injuries.

Our representatives are available 24/7 to offer you a free and confidential evaluation of your case. You can also use our live chat feature or send in our secure and confidential form on this page. It takes just a few minutes to provide us the information we need to determine if you may have a case.

Call the Law Offices of James Scott Farrin at 1-866-900-7078 to find out if one of our North Carolina lawyers may be able to help you.

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The Law Offices of James Scott Farrin consults with a national network of attorneys on product liability, defective drugs, and defective products cases in an attempt to provide the best representation we can for our clients. Depending on the details of your case, our firm will likely refer your matter to another law firm with which we associate. We will only do this if we believe it is in your best interests and if you agree.