FDA announces class I recall of DePuy LPS Diaphyseal Sleeve

The FDA announced a class I recall of the DePuy Orthopaedics LPS Diaphyseal Sleeve that was manufactured from 2008 to July 20, 2012, after reports of fractures and loosening. The recall was initiated Feb. 15 and on Jan. 4, DePuy issued an urgent medical device recall for the product, which is used in knee arthroplasty revision surgery.

The taper connection of the LPS Diaphyseal Sleeve to the Diaphyseal Sleeve Base may be insufficient for loads possibly transferred to the junction during normal gait in some patients, according the FDA notice.

“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.”

According to the notice, the FDA has received 10 incident reports (6 fractures, 4 loosenings) that indicate the device malfunctioned. Complications from fracture of the sleeve at the taper joint could also lead to loss of function or limb, compromised soft tissue, infection, or death.

In DePuy’s January recall notice, the company urged hospitals and physicians to stop distributing and using recalled lots of the implant, and noted all lot numbers with the following product codes should be returned to DePuy Orthopaedics:

1987-20-018
1987-20-020
1987-20-024
1987-20-028

The FDA is recommending patients and health care professionals report adverse events or side effects related to this product to the FDA MedWatch Safety Information and Adverse Event Reporting Program.

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 death.

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