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On August 1, 2013, the Food and Drug Administration (F.D.A.) issued a Class I recall notice regarding DePuy Orthopaedics’ Limb Preservation System (LPS) Lower Dovetail Intercalary Component. This device was implanted in patients as a replacement of portions of the femur affected by trauma, tumors or infections. The LPS device was marketed and distributed by DePuy Orthopaedics from February 2007 to March 2013.
The LPS device is being recalled due to the potential for fracture of the device while walking. Specifically, those patients who weigh more than 200 pounds and those who are highly active are at an increased risk of fracture. Fracture can subsequently lead to complications such as a need for revision surgery, loss of limb and loss of function.
DePuy Orthopaedics issued a recall of the LPS device on July 11, 2013 to hospitals, surgeons and distributors. The F.D.A. indicates that Class I recalls are the most serious kind of recall, involving products that can cause serious injury or death. Patients who have been implanted with this device should follow up with their doctor, particularly if they are experiencing any type of adverse symptom.
See the F.D.A. Medical Device Recall:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm363452.htm
See the F.D.A. Safety Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm363505.htm
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