The FDA has released a class I recall of the DePuy Orthopaedics LPS Diaphyseal Sleeve that was manufactured from 2008 to July 20, 2012, after multiple reports of fractures and loosening. DePuy issued an urgent medical device recall for the product, which is used in knee arthroplasty revision surgery. The FDA has received 10 incident reports (6 fractures, 4 loosenings) that indicate the device malfunctioned. Complications from fracture of the sleeve at the taper joint could also lead to loss of function or limb, compromised soft tissue, infection, or death.
For full recall information, click here.