FDA Class I Recall: DePuy LPS Diaphyseal Sleeve

fda-class-1-Depuy-lps-diaphysealIn the midst of the first of some 10,000 lawsuits over the DePuy Orthopaedics recalled ASR metal-on-metal hip device, the U.S. Food and Drug Administration just announced a Class I recall of another device manufactured by DePuy. DePuy Orthopaedics is a unit of Johnson & Johnson.

The FDA just announced that DePuy Orthopaedics recalled its Limb Preservation System (LPS) Diaphyseal Sleeve, said Healio.com. The recalled sleeve was manufactured from 2008 to July 20, 2012 and was recalled following reports of sleeve fracture and device loosening. The recall was initiated on February 15; on January 4, DePuy issued an urgent medical device recall for the sleeve.

The urgent medical device recall informed hospitals and surgeons of the problem and advised that they should immediately stop distributing or using the recalled lots. If a medical facility in in possession of the affected product, it should return the device to DePuy. According to the recall, in some patients, the LPS Diaphyseal Sleeve’s taper connection to the Diaphyseal Sleeve Base may be insufficient for loads that are potentially transferred to the device’s junction during normal walking, said Helio.com, citing the FDA recall notice.

The recalled LPS Diaphyseal Sleeve is used in knee arthroplasty revision surgery and is meant for use with the LPS System, an end-stage revision knee product that enables surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve is meant to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.

The federal regulator stated that it has received 10 incident reports, to date. Of the reports, six involve fractures and four involve the device loosening, which indicates that the DePuy LPS Diaphyseal Sleeve malfunctioned.

The FDA stated that, “DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device…. 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.”

A Class I recall designation is the FDA’s most serious and involves a situation in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. In this case, noted Helio.com, complications from an LPS Diaphyseal Sleeve at the taper joint could be significant and even fatal and could lead to loss of function, loss of the limb, compromised soft tissue, infection, or death.

In DePuy’s January recall notice, the device maker urged hospitals and physicians to stop distributing and using recalled lots of the implant, and stated that 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 recommends that patients and health care professionals report adverse events or side effects related to the LPS Diaphyseal Sleeve be reported to the FDA MedWatch Safety Information and Adverse Event Reporting Program.

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