Medical device maker Stryker Corp. has issued updated guidance for patients who rely on the company’s ABG II Modular neck hip implant component.
According to a report at MassDevice.com, a recent finding that one patient who showed no other signs of complications caused by this recalled metal hip implant component but had elevated levels of metallic ions in their bloodstream prompted Stryker to issue updated safety guidance. Stryker informed Australia’s Therapeutic Goods Administration (the country’s answer to the Food and Drug Administration) of its suggested updated guidance, which in turn issued a public advisory.
Stryker recalled the ABG II and Rejuvenate metal hip implant component parts in July 2012 because they are prone to corrosion and “fretting” that can cause recipients to suffer severe pain, inflammation, and elevated levels of metallic ions in their bloodstream. Though the recalled devices are component parts designed to be used as a metal-on-metal hip implant, recipients of these device components had begun reporting complications consistent with those using a failed all-metal hip implant.
At the time of the recall, Stryker advised surgeons and recipients of the ABG II component device to continue with regular monitoring for complications. If a recipient of these devices, especially the ABG II, did not show any signs of complications, their physicians had been advised to continue routine monitoring but not to take any additional steps.
In that time since the recall, one patient fitted with the ABG II device who was not experiencing any of the physical side effects of a defective device showed elevated levels of metallic ions in their bloodstream. This complication is caused by metal hip implant components rubbing together through normal use and can cause serious internal injuries. Elevated metallic ion levels in the bloodstream can lead to tissue and organ damage, especially at the site of the implant.
Now, Stryker is advising doctors and recipients of the ABG II device to undergo more vigilant monitoring for signs of complications, even if they’re not experiencing any other signs of trouble that could be linked to the implant component device. Recipients of the ABG II device, under Stryker’s new advisory, should undergo routine blood testing and soft tissue cross-sectional imaging to determine if the device is causing otherwise unnoticed injuries.
If a patient’s blood tests show signs of complications caused by elevated metallic ion levels, a revision surgery to remove the flawed component should be considered before more damage is caused. A total of 258 ABG II devices have been implanted in Australia since 2007 but none have been sold since February of last year.