The LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component is being recalled because it has 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 recalled products were manufactured and distributed from February 2007 through May 2013.
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.).
The manufacturer, DePuy Orthopaedic, Inc, 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.
If a patient presents with a fractured LPS Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines that replacing the LPS Lower Extremity Dovetail Intercalary component is the best treatment option, DePuy will make the LPS Lower Extremity Dovetail Intercalary component available. If the LPS Lower Extremity Dovetail Intercalary component has fractured and the surgeon determines that the replacement LPS Lower Extremity Dovetail Intercalary component is not the best treatment option for a patient, other commercially available products should be considered.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, July 2013 Report: New Hips, New Knees, New Problems: Hip and Knee Replacements