FDA Updates Metal-on-Metal Hip Information

Attorneys Fred Pritzker and David Szerlag are representing over 60 patients with metal-on-metal hip implants. They recently won over $40 million for clients injured by another medical product, and have now filed lawsuits against manufacturers of metal-on-metal hip replacement implants.  You can contact Fred and David for a free consultation here.

The FDA is providing updated safety information on metal-on-metal hip implants to patients and healthcare professionals, including orthopaedic surgeons and radiologists. The new information is based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.

In metal-on-metal hip implants (Stryker, DePuy, Smith & Nephew), one metal part slides against another during walking or running. This causes tiny metal particles (chromium and cobalt) to wear off of the device around the implant, which may cause damage (including necrosis, which means death) to bone and/or soft tissue surrounding the implant and joint. Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery, which involves removing and replacing the metal-on-metal product. Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body.

Report Problems with Your Metal-on-Metal Hip to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Reports about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.

New FDA Patient Follow-Up Recommendations

If you do not have revision surgery to remove the metal-on-metal hip implant, the FDA recommends that your doctor provide follow-up care:

  • Follow-up of asymptomatic patients with metal-on-metal hip implants, including physical examinations and routine radiographs, should occur periodically (typically every 1 to 2 years).  If the hip is functioning properly, the FDA does not believe there is a clear need to routinely perform additional soft tissue imaging or assess metal ion levels in the blood.
  • Be aware that there are certain patients who are at risk for increased device wear and/or adverse local tissue reactions (ALTR) and should be followed more closely. They may include:
    • Patients with bilateral implants
    • Patients with resurfacing systems with small femoral heads (44mm or smaller)
    • Female patients
    • Patients receiving high doses of corticosteroids
    • Patients with evidence of renal insufficiency
    • Patients with suppressed immune systems
    • Patients with suboptimal alignment of device components
    • Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
    • Patients who are severely overweight
    • Patients with high levels of physical activity.
  • Pay close attention to signs and symptoms that may be associated with metal-on-metal hip implants.
  • Conduct a thorough evaluation if a patient with a metal-on-metal hip experiences local symptoms such as pain or swelling at or near the hip, a change in walking ability or a noise from the hip joint more than three months after metal-on-metal hip implant surgery.
  • Follow symptomatic patients with metal-on-metal hip implants at least every 6 months.

You may also need diagnostic imaging to assess and diagnose soft tissue findings surrounding the implant.  This is a problem because of the dangers of having an MRI with the metal implants. If your doctor determines that an MRI of a metal-on-metal hip implant patient is appropriate, the FDA recommends the following:

  • Consult with the radiologist to evaluate the benefits and risks of utilizing MRI with metal artifact reduction;
  • Review the available device-specific labeling from manufacturers for MRI Conditions; and
  • Inform the MRI site that the patient has a metal-on-metal hip implant.

Assessing Metal Ion (Chromium and Cobalt) Levels

Some patients with a metal-on-metal hip implant may have elevated metal ion levels (e.g. cobalt and/or chromium) in their bloodstream.  Several factors can impact the accuracy, reproducibility, and clinical interpretation of metal ion test results.  Below are the FDA’s recommendations:

  • The FDA does not believe there is a clear need to routinely check metal ion levels in the blood if the orthopaedic surgeon feels the hip is functioning properly and the patient is asymptomatic.
  • Patients with metal-on-metal hip implants who develop any symptoms or physical findings that indicate their device may not be functioning properly, should be considered for metal ion testing.
  • If measuring metal ions, consider obtaining and following serial measurements (using the same sample type, the same measurement method, and preferably the same laboratory) in determining metal ion levels in symptomatic patients.
  • At this time, the FDA is not recommending a specific metal ion level as a trigger for revision or other medical intervention.  The metal ion concentration values, including increases in metal ion levels over time, should be considered in addition to the overall clinical scenario including symptoms, physical findings, and other diagnostic results when determining further actions.

Revision Surgery

Many of Fred and David’s patients have had or are scheduled to have revision surgery to remove and replace the metal-on-metal hip implant. The FDA is warning doctors that, in case of adverse local tissue reactions (ALTR), revision of a metal-on-metal hip implant may have a worse prognosis than revision of other types of bearing surfaces.

In selecting components for revision the FDA recommends your doctor do the following:

  • Consider the benefits and risks of all bearing surfaces for each patient.
  • Check the specific device labeling for compatibility of device components.
  • If a patient is suspected to have developed metal sensitivity, carefully select the materials of the revision components (potentially avoiding materials with nickel or chromium).

FDA Recommendations for Patients with Metal-on-Metal Hip Implants

  • If you are not having any symptoms and your orthopaedic surgeon believes your implant is functioning appropriately, you should continue to routinely follow-up with the surgeon every 1 to 2 years.
  • If you develop new or worsening problems such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in your ability to walk, contact your orthopaedic surgeon right away.
  • If you experience changes in your general health, including new or worsening symptoms outside your hip, let your physician know you have a metal-on-metal hip implant.


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