Federal healthcare regulators put their highest-risk Class I label on a recall of Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics’ Limb Preservation System after the company warned that certain components may fracture and harm patients.
The recall affects 16 lot numbers of the LPS devices, covering those manufactured between February 2007 and May 2013, according to the FDA notice.
In earlier notices, flagged by the Hong Kong Dept. of Health, DePuy warned that the female component of the affected part – called the lower extremity dovetail intercalary component – might break under abnormal force loads. The new warning adds that the devices may break "when exposed to normal physiologic loads while walking."
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 immediately, but is not recommending revision surgeries or additional follow-up unless a patient has problems with the implant.