As reported today, the manufacturer of the Stryker Trident ceramic on ceramic system, Howmedical Osteonics issued a voluntary global recall for two hip implant components after the Food and Drug Association determined that it “failed to act on patient claims the products caused bone fractures and required corrective surgery.”
As reported, Stryker Australia recalled the components – Trident Hemispherical and Trident PSL shells - of its Trident system in late January of 2008, but the Australian public was not notified of the recall as it was voluntary.
Alarmingly, as reported, Therapeutic Goods Administration documents show problems regarding the artificial hip component were first raised in Australia in 2001.
But The Age can reveal that the FDA also cautioned the company’s Irish subsidiary after a 2006 investigation found several problems regarding the making of the implants in Cork, Ireland.
