Saturday, February 23, 2013

FDA announces Class I recall of DePuy LPS Diaphyseal Sleeve

The FDA announced a Class I recall of the DePuy Orthopaedics LPS Diaphyseal Sleeve that was manufactured from 2008 to July 20, 2012, after reports of fractures and loosening. The recall was initiated February 15 and on January 4, DePuy issued an urgent medical device recall for the product, which is used in knee arthroplasty revision surgery.

The taper connection of the LPS Diaphyseal Sleeve to the Diaphyseal Sleeve Base may be insufficient for loads possibly transferred to the junction during normal gait in some patients, according the FDA notice.
“DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device,” the FDA stated. “However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing these symptoms.”