August 1, 2013 — DePuy Orthopedics and the U.S. Food and Drug Administration (FDA) have announced a Class 1 recall of the LPS Lower Extremity Dovetail Intercalary component. This is a component of the Limb Preservation System (LPS), a line of implants used in lower-leg reconstructive surgery. According to the recall notification, the component can fracture at the dovetail during normal walking activities.
The recall affects products that were manufactured and distributed from February 2007 until May 2013.
The FDA warns about the following complications of a fractured implant:
“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. Patients greater than 200 pounds and/or those with high levels of activity are at higher risk of fracture.”
On July 11, 2013, DePuy issued an Urgent Medical Device Notification to warn distributors, hospitals, and surgeons about the problem. DePuy instructed surgeons to immediately stop implanting the products. They are not recommending routine revision surgery or any additional follow-up for patients who are not having symptoms or problems with their implant.
This is not the first recall involving the DePuy Limb Preservation System (LPS). In February, DePuy recalled the LPS Diaphyseal Knee Sleeve in February 2013. The problem was that a tapered connection point could fracture during normal walking activities.