The FDA has issued a Class I recall of Depuy’s LPS Diaphyseal Sleeve. The sleeve is intended for use with the LPS system, an end-stage revision knee product that allows for surgical reconstruction of severe soft tissue and bony defects. The diaphyseal sleeve is used to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.
Reason for Recall
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 norma gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.
Several reports of incidents in which the device has malfunctioned have been received. The reports include fractures as well as loosening. Surgeons are being urged to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.
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 in some cases, death. Hospitals and surgeons were advised to immediately stop distributing or using the recalled lots.
Possible DePuy LPS Diaphyseal Sleeve Complications
The LPS Diaphyseal Sleeve has known complications attributed with its use which may include:
- Fracture of the sleeve at the taper joint
- Device loosening
- Loss of function
- Loss of limb
- Compromised soft tissue
If you or a loved one has experienced complications or signs of device failure within a few years of receiving a DePuy LPS Diaphyseal Sleeve implant or knee implant components, you may need to make an appointment to see an orthopedist immediately.
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