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.

FDA Investigation

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
  • Infection
  • Compromised soft tissue
  • Death

Contact us

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.

Please contact Bernheim and Dolinsky, LLC today at 1-800-474-4089 or online to discuss the particular facts of your potential case.  Our experienced dangerous products attorneys will discuss your potential case and explain what we can do for you.

Please call us today for a free consultation.  Our dangerous products attorneys handle cases on a contingency fee basis meaning that there are no fees or costs unless you recover money for your damages.

Our attorneys are available 24 hours a day, 7 days a week to answer your calls or emails in regards to a potential case.  When you call, you can speak with a dangerous products attorney who can communicate with you in English, Spanish and French Creole.

We offer:

  • Free, no-obligation case evaluation.  No fee unless you recover.
  • Flexible appointments.
  • Home and hospital visits.
  • Experienced lawyers helping clients nationwide.

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