DePuy Orthopedics has recalled defective components of the Limb Preservation System (LPS) because they can fracture during normal walking activities. The DePuy LPS recalls include the LPS Diaphyseal Sleeve and the LPS Lower Extremity Dovetail Intercalary Component, which are used in knee replacement, femur replacement, and lower-leg reconstructive surgery.
What is the DePuy LPS?
DePuy Orthopedics manufactures the Limb Preservation System (LPS), an implant used in reconstructive surgery in the lower leg, knee, and femur. The DePuy LPS repairs extensive bone loss caused by severe trauma, infections, or tumors.
DePuy LPS Femur Replacement Recalls
DePuy has recalled components of the LPS because they can fracture during normal walking activities. The following DePuy LPS components have been recalled by the U.S. Food and Drug Administration (FDA):
- August 1, 2013 — Lower Extremity Dovetail Intercalary Component
- February 22, 2013 — LPS Diaphyseal Sleeve
DePuy LPS Lower Extremity Dovetail Intercalary Component
The LPS Lower Extremity Dovetail Intercalary Component is a component of a femur replacement used in the DePuy LPS. It was manufactured from February 2007 until May 2013. The component is used for total femur replacement, mid-shaft, top, or bottom. It may also be used in tibia replacement surgery.
The LPS Lower Extremity Dovetail Intercalary Component was recalled:
“…due to the potential for fracture of the female component, at the dovetail, when exposed to normal physiologic loads while walking. … Patients greater than 200 pounds and/or those with high levels of activity are at higher risk of fracture.”
DePuy LPS Diaphyseal Sleeve
The LPS Diaphyseal Sleeve is a component that enhances the fit of the femur into a knee replacement. It was manufactured from 2008 until July 2012. DePuy and the FDA issued a recall after receiving 10 adverse event reports, including 4 reports of loosening and 6 reports of fractures during normal walking activities.
The LPS Diaphyseal Sleeve was recalled because:
“The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint.”
Talk to your orthopedic surgeon about symptoms of a fracture and what to do if you experience this complication. If you are not having symptoms, DePuy does not recommend revision surgery or additional follow-up. These symptoms may include:
- Severe pain
- Abnormal appearance of the leg
- Bruising or discoloration
- Nerve damage
- Loss of limb function
- Internal bleeding
- Decreased walking ability