An article in Australia’s Sydney Morning Herald reported that the Osseointegration Group of Australia, owned by surgeon Munjed Al Muderis, continued to use a faulty part in its osseointegration (OI) surgery that the company knew caused patients to fall and injure themselves.
The newspaper said documents it obtained showed the company declined to launch a formal recall of the faulty part even after its clinical researcher recommended immediate action be taken.
A 2018 draft research report from Osseointegration Group of Australia found that the Type B dual cone, a crucial connecting component of the OI implant that was designed by the company, carried an “unacceptable” risk of breaking, with “high probability of occurrence and high consequence of hazard.”
According to the newspaper, the report said 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,” the report said, and recommended the part be immediately discontinued. The company told Australia’s medical regulator that it stopped using the faulty part in February 2019.
Osseointegration Group of Australia initially planned to launch a formal recall, but later said it was unclear what caused the breakages and therefore would only recommend replacement if a patient was heavy or lived an active lifestyle. Australia’s Therapeutic Goods Administration, which regulates medical devices, was alerted in 2018 to the number of breakages and approved the company’s approach.
Lawyers for Al Muderis told newspapers that all complaints had been investigated by the regulators and dismissed. The lawyers said dual cones need to be regularly replaced and that patients are responsible for maintaining their parts.
The selective replacement approach was privately criticized within the company’s own team of doctors, one of whom filed an official complaint with the medical regulator, the Australian Health Practitioner Regulation Agency, in December 2018 saying the implant had not gone through sufficient testing before being used in more than 100 patients from Australia, the United Kingdom, and the United States.
Al Muderis said he was not responsible for the breakages. “I’m a clinician. I’m a surgeon. We need to separate here between the engineering side and the manufacturing side … I own the patent. I designed the parts, but I wasn’t the engineer.”
After the newspaper story, Al Muderis’ medical insurance was revoked, and he was suspended from consulting or operating on patients undergoing OI. The ban will take effect October 3 and will last until an investigation by the insurer is completed.
