DePuy Orthopaedics issued a Class 1 Recall of its Limb Preservation System (LPS) Lower Extremity Dovetail Intercalary Component on July 11, 2013 because the female component of the device has the potential to fracture at the dovetail while a patient walks.
DePuy advised distributors, hospitals and surgeons of the problem and urged them to immediately stop distributing or using the recalled lots, which include about 32 lot numbers.
In addition to severe pain, individuals who experience a device fracture can suffer infections, dislocation, loss of leg function or neurovascular injury. Patients can suffer damage to the bone in areas necessary for revision surgery, so surgeons may be unable to conduct a revision if there is a lack of sufficient bone stock. This problem can result in amputation if no other options are available. Patients who weigh more than 200 pounds and those with high levels of activity are at higher risk of fracture.
I asked my colleague, medical device lawyer Thomas Anapol, what he thought of the situation. “DePuy has issued yet another Class 1 Orthopedic recall,” he said. “A failed Limb Preservation System potentially exposes patients to catastrophic injuries including amputation.”
The LPS was manufactured and distributed between February 2007 and May 2013. The recall has not indicated how many products are on the market. DePuy has received 7 complaints of fracture.
The LPS is intended to replace the mid-shaft portion of the femur, top, bottom or total femur, and top tibia, especially in cases that require extensive resection, such as tumors, trauma and infection.
“Significant bone loss requiring extensive reconstruction around the hip and knee is often required following the treatment of malignant bone tumors, aggressive benign bone tumors, infection, multiple revised and failed joint replacements and massive trauma,” according to DePuy.