Stryker Australia Advises Closer Watch on Patients with Recalled Hip Implants
Health regulators in Australia received updated recommendations from Stryker Australia for monitoring patients who have received the company’s ABG II Modular metal-on-metal hip implants.
The implants – specifically the ABG II Modular necks – were voluntarily recalled last year by Stryker over concerns they may be susceptible to fretting and corrosion at the modular-neck junction, which may trigger pain and adverse reactions in nearby tissue. The company also recalled its Rejuvenate Modular femoral stems in 2012 for the same issue.
Australia's Therapeutic Goods Administration released the new guidelines calling for physicians to follow up with patients even if there is no report of pain or swelling with the hip devices, according to Mass Device. The guidelines recommend regular blood testing and soft tissue cross-sectional imaging for all ABG II patients.
Previously, it was recommended that patients implanted with the ABG II implants undergo regular monitoring but have blood work or other tests only if a patient felt pain or has swelling, which could suggest a wear issue with the implant, writes Mass Device. The new guidelines now advise that patients without symptoms also be monitored through regular blood tests and imaging along with repeat follow-up and evaluation. Revision surgery – the replacement of a device – is recommended if any traces of metal particles are found in the patient’s blood stream.
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