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Home / FDA Announces Class I Recall of DePuy LPS...

FDA Announces Class I Recall of DePuy LPS Diaphyseal Sleeve

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The FDA recently released a Safety Alert regarding the class I recall of the DePuy Orthopaedics LPS Diaphyseal Sleeve.  According to the agency, the taper connection from the LPS Diaphyseal Sleeve to the Diaphyseal Sleeve Base may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.

Currently, 10 incidents (6 fractures, 4 loosenings) have been reported to the FDA in which the device has malfunctioned. The cause of the reported device issues has yet to be determined.

“DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device,” the FDA stated. “However, DePuy is encouraging surgeons 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 these symptoms.”

This recall is a follow up to the January recall notice in which DePuy urged hospitals and physicians to stop distributing and using recalled lots of the implant.

An FDA Class 1 recall indications a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

For more information, view the full FDA Medical Device Recall.

If you or someone you know has been injured by a defective hip implant call Longo Legal, PLLC to find out if you have a potential claim.  The first step is to get some preliminary information over the phone.  The initial phone call and consultation cost you nothing.  You will not pay Longo Legal, PLLC anything towards your DePuy lawsuit unless a recovery is made on your behalf.  Call Longo Legal at (855) 566-4648 to see if you qualify.

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