continued to use a faulty medical part that the company knew caused amputees to fall and injure themselves.show the company declined to launch a formal recall of the faulty part even after its clinical researcher recommended immediate action be taken.
A 22-page draft research report from Al Muderis’ company, Osseointegration Group of Australia, found in April 2018 that the part, which was designed by the company, carried an “unacceptable” risk of breaking, with “high probability of occurrence and high consequence of hazard”. According to the report, the “widespread” and “spontaneous” breakages of the part occurred at a higher rate than competing models and were not confined to any particular batch or size. Changing parts after they break can be a “lengthy and extremely undesirable process”, involving several hours of drilling, the report said.The company initially planned to launch a formal recall and began collecting images and information to send to the manufacturer, Permedica.