The Hong Kong Department of Health issued a Safety Alert following DePuy Orthopaedics‘ discovery that part of its Limb Preservation System may fracture under pressure.
DePuy, a Johnson & Johnson (NYSE:JNJ) subsidiary, said the female component of the affected part – called the lower extremity dovetail intercalary component – might break under abnormal force loads.
The device is especially vulnerable in patients who weigh over 200 lbs, especially during more robust activities like suddenly standing or climbing up and down stairs, according to the Hong Kong report.
If the piece fractures, patients could lose motor function, experience joint dislocation or tissue damage, or experience other harmful events that require follow up surgery. Hospitals and care centers have been warned to stop using parts with lot number 1987-19-055.
The company said patients with the implant but without symptoms do not need to have the device removed, but surgeons should keep in mind weight and activity level when consulting with future patients, according to the safety alert.