Parker Waichman LLP is investigating potential lawsuits on behalf of individuals who have been implanted with the DePuy LPS Diaphyseal Sleeve, which is used in the DePuy LPS Limb Preservation System. This product is an end-stage revision knee device intended to correct severe soft tissue and bone defects.
The U.S. Food and Drug Administration (FDA) has issued a class I recall of the LPS Diaphyseal sleeve due to the risk of fracture, which can have serious adverse health consequences, including death. If you or someone you know was injured after receiving the LPS system with the Diaphyseal Sleeve component, you may have valuable legal rights. Contact Parker Waichman LLP
today for a free, no-obligation evaluation of your case.
DePuy LPS Recalled Due to Risk of Fracture – May Lead to Serious, Fatal Consequences
The DePuy LPS is an end stage revision product in which the mid-shaft portion of the femur, proximal, distal and/or total femur and proximal tibia are replaced. This knee revision device can be used with a number of component options, including sleeves, adapters, stems, or insert bearings. These components are used when patients suffer from bone loss and deformity related to bone tumors resection, trauma, infection and difficult revision arthroplasty. A diaphyseal sleeve is a sleeve used for the shaft of the long bone; according to the FDA, this component “is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.” However, this product has been recalled due to a risk of fracture, which can have serious or even fatal consequences.
FDA Issues a Class I Recall
On January 4, 2013 DePuy issued an Urgent Medical Device Recall warning hospitals and surgeons about the risk of fracture with the DePuy LPS Diaphyseal Sleeve. Healthcare professionals were told to stop using the device and any in stock were to be sent back to the company. The following month, the FDA issued a class I recall of the LPS Diaphyseal sleeve, stating that the taper connection between the sleeve and base may not able to sustain the physiological loading during everyday activities in some patients. The FDA warned that this may lead to a fracture of the sleeve at the taper joint, which may cause:
- Loss of function
- Loss of limb
- Compromised soft tissue
At the time the product was recalled, the FDA said it had received a total of 10 reports of device malfunction. This includes six cases of fracturing and 4 reports of loosening. The recalled sleeves were manufactured between 2008 and July 20, 2012. The Product Codes and Lot Numbers included in the recall are:
|Part #||Lot #|
A class I recall is the FDA’s most serious recall status; it means that exposure to the product presents a reasonable risk of serious injury or death.
Legal Help for Victims of DePuy LPS Diaphyseal Sleeve Injuries
If you or a loved one received the DePuy LPS Diaphyseal Sleeve used in the LPS system and experienced complications, including sleeve fracture, you may have valuable legal rights. Please fill out our online form or call 1(800)-YOURLAWYER (1-800-968-7529) to speak with one of our experienced medical device attorneys today.