FORT LAUDERDALE, Fla.
- Aug. 8, 2013
-- The Food and Drug Administration along with DePuy Orthopaedics recently notified healthcare professionals of a class 1 recall for the LPS Lower Extremity Dovetail Intercalary Component due to the potential for fracture of the female component when exposed to normal physiologic loads while walking. This failure may lead to pain, loss of function, infections, loss of limb, neurovascular injury or the need for revision surgery. Patients who are highly active or who weigh more than 200 pounds have the greatest risk of fracture.
The LPS Lower Extremity Dovetail Intercalary component is a device intended for replacement of the mid-shaft portion of the femur, top, bottom and/or total femur and top of the tibia. It is particular used in cases requiring extensive resections such as cases involving tumors, trauma or infections. . On July 11, 2013 DePuy issued an Urgent Medical Device Recall to DePuy distributors, hospitals and surgeons warning them of the problem and to immediately stop distributing or using the recalled lots.
DePuy is also providing a patient letter template, which may be used by surgeons to notify and discuss with patients the risks of the implant and how to detect potential implant failure. At this time, DePuy is not recommending revision or replacement surgery in patients without any symptoms from the implanted device. A full list of the affected product codes and lot numbers may be found on the FDA website at http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/uc...
Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who received a DePuy device by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.