Knee Replacement Medical Device Recalled

The US Food and Drug Administration  (FDA) has notified healthcare professionals of a Class I recall of the LPS Diaphyseal Sleeve, a manufactured medical device used in human knee replacement surgery.

It has been found that The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.

The device was manufactured by: DePuy Orthopaedic, Inc, a company owned by Johnson and Johnson.