Recall Class: Class I
Date Recall Initiated: July 11, 2013
Product: LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component
These products were manufactured and distributed from February 2007 through May 2013.
Product Codes and Lot Numbers:
|Lot Numbers||Lot Numbers|
** In certain documentation, these alphanumeric lot numbers may appear with three zeroes at the end (e.g. A1TAR1 may appear as A1TAR1000).
Use: 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.).
DePuy Orthopaedic, Inc
700 Orthopaedic Drive
Warsaw, IN 46581
Reason for Recall:
The LPS Lower Extremity Dovetail Intercalary component 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.
Public Contact: Questions should be directed to Kim Earle, Recall Coordinator at 574-371-4917, Monday through Friday from 8 am to 5 pm Eastern Time.
FDA District: Detroit
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.
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.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.