On February 22, 2013, the U.S. Food & Drug Administration (FDA) posted that it notified healthcare professionals regarding a Class I recall of the LPS Diaphyseal Sleeve. The LPS Diaphyseal Sleeve is a component in the DePuy LPS System, an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
The defect in the product is 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.”
Currently, the FDA has received 10 reports of the device malfunctioning. Of those 10, there are 6 reports of fractures and 4 reports regarding loosening. It has not yet been determined if those 10 reports are due to the device issues necessitating the recall. DePuy is encouraging those patients with the affected device to communicate with their surgeons regarding “the risks of implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.” In other words, patients with the affected device may experience fractures and loosening and need to be vigilant in early detection of those possible issues.
Currently, DePuy Orthopedics, a subsidiary of Johnson & Johnson, is facing thousands of lawsuits around the country for defects and failures regarding its hip replacement devices. The DePuy ASR XL Acetabular System was recalled in August of 2010, and has been dubbed the “Hurricane Katrina” of medical implant disasters. Among other criticisms, DePuy is facing allegations that it knew of defects in its ASR device long before the recall. It is not clear yet how long DePuy knew of the problems with its LPS Diaphyseal Sleeve product that it recently recalled. One can only hope that DePuy learned from the mistakes of its past and is being proactive this time about patient safety.