Stryker Issues Updated Guidance for ABG II Metal Hip Implant Component RecipientsFeb 21, 2013
Medical device maker Stryker Corp. has notified health officials in Australia of new clinical guidance for patients wearing the company’s ABG II Modular hip implant component.
According to a report from MassDevice.com, the company’s Australian division notified that country’s Therapeutic Goods Administration this week on new guidance for physicians treating patients who wear the now-recalled ABG II hip implant component device.
In July of last year, Stryker issued recalls on the ABG II and Rejuvenate after admitting that the all-metal components of a hip implant were prone to corrosion and “fretting” that caused recipients of the devices to suffer severe pain, inflammation, and loosening of the implants. All these complications are common complications associated with the use of metal-on-metal hip implants.
After the recall, Stryker advised patients and doctors to remain vigilant against signs of these complications that prompted the recalls on the devices. Until those complications presented themselves, doctors were told to continue with regular monitoring of these patients. They should only conduct blood testing and image scans on these patients if they complained of any of the complications consistent with these troubled devices.
In its updated safety communication, Stryker now advises physicians to be a little more vigilant against signs of trouble. According to the report, physicians should now conduct regular blood tests as well as “soft tissue cross-sectional imaging” for any patient of theirs who wears the ABG II device. Physicians should conduct these regular tests even if their patient is not complaining of any problems.
The increased testing is designed to detect signs of metallic ion accumulation in the bloodstream of patients wearing the ABG II device. One of the hallmark complications of wearing an all-metal hip implant is the dangerous build-up of metals cobalt and chromium caused by normal wear of these devices, including the component parts recalled by Stryker last year. Even patients who show no other signs of trouble with their devices that use the ABG II component should be tested regularly.
The updated advisory from Stryker was actually prompted by reports from Australian physicians who noted one recipient of the ABG II device who had undergone regular monitoring for trouble with the device but blood tests showed a dangerous accumulation of metallic ions. The patient had begun to experience internal tissue damage caused by this toxic build-up.
Patients who rely on metal-on-metal hip implants face a serious risk of organ and tissue damage caused by the accumulation of these metallic ions. Metallic particles are shed into the bloodstream of recipients through normal wear of their devices.