August 1, 2013 — A recall has been issued for a component of the DePuy Limb Preservation System (LPS). The Lower Extremity Dovetail Intercalary component is part of a lower-leg implant used in reconstructive surgery. According to the FDA Class 1 recall notification, the component can fracture under normal physical loads.
The recalled DePuy LPS component was manufactured from February 2007 until May 2013.
DePuy began the recall on July 11, when they sent an “Urgent Medical Device Notification” to surgeons, hospitals, and distributors. DePuy warned surgeons to stop implanting the component. For patients who are already implanted with the product, DePuy does not recommend revision surgery or follow-up unless the patient is having problems with their implant.
The FDA has warned that fractures are more likely to affect patients with high activity levels and/or those who weigh more than 200 pounds. According to the FDA, a fractured component may cause the following complications:
“The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component, at the dovetail, when exposed to normal physiologic loads while walking. This may also lead to additional pain, infection, loss of function, loss of limb, neurovascular injury or need for revision surgery.
This is the second major recall involving the DePuy Limb Preservation System (LPS) this year. In February, DePuy issued a Class 1 recall of the LPS Diaphyseal Knee Sleeve. Like the DePuy LPS dovetail component, the problem was that the taper connection could fracture during normal walking activities.