August 2, 2013
The US Food and Drug Administration (FDA) and DePuy Orthopaedics have notified health care professionals of a 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 pounds and/or those with high levels of activity are at higher risk of fracture.
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.).
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 for further recommendations and a list of affected product codes and lot numbers.