Class 1 Recall - Potential for Fracture of Device

DePuy Orthopaedics-LPS Lower Extremity Dovetail Intercalary Component Recalled

August 7, 2013

AUDIENCE: Orthopedic Surgery, Risk Manager

ISSUE: FDA and DePuy Orthopaedics notified healthcare professionals of the class 1 recall of the LPS Lower Extremity Dovetail Intercalary Component due to 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 lb and/or those with high levels of activity are at higher risk of fracture.

BACKGROUND: The LPS Lower Extremity Dovetail Intercalary component is intended for replacement of the mid-shaft portion of the femur, top (proximal), bottom (distal) and/or total femur, and top (proximal) tibia, especially in cases that require extensive resection (i.e. tumors, trauma, infections, etc.).

RECOMMENDATION: On July 11, 2013 DePuy issued an Urgent Medical Device Recall informing DePuy distributors, hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. DePuy is providing a patient letter template to assist surgeons with notifying and discussing the risks of the implant fracture and the method for detecting implant failure with their patients. DePuy is not recommending revision or additional follow up  in the absence of symptoms of patients with this implanted device.Read the complete FDA recall notice, linked below, for further recommendations and a list of affected product codes and lot numbers.

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