FDA Announces DePuy LPS Diaphyseal Sleeve Class I RecallFeb 25, 2013
The U.S. Food & Drug Administration (FDA) just announced the Class I recall of DePuy Othopaedic’s Limb Preservation System (LPS) Diaphyseal Sleeve. DePuy Orthopaedics is a unit of health care products giant, Johnson & Johnson.
According to the federal regulator, the recalled DePuy LPS Diaphyseal Sleeve, which is used in knee arthroplasty revision surgery, was manufactured from 2008 to July 20, 2012. The recall followed reports of sleeve fracture at the taper joint and device loosening. The device recall was initiated on February 15; on January 4, DePuy issued an urgent medical device recall for the sleeve, which informed hospitals and surgeons of the problem and advised that they immediately cease distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to DePuy.
The LPS Diaphyseal Sleeve 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 intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.
Some patients, according to the recall notice, experience significant issues during normal walking because 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 typical walking. “DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device,” said DePuy, according to the FDA release. “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,” the release continued.
The agency stated that it has received 10 incident reports, to date. Of the reports, six involved fractures and, four, device loosening. All of the incident reports indicate that DePuy’s LPS Diaphyseal Sleeve malfunctioned.
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, complications from an LPS Diaphyseal Sleeve failure 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 all recalled lots of the implant, and stated that lot numbers with the following product codes should be returned to DePuy Orthopaedics:
The FDA recommends that patients and health care professionals report adverse events or side effects related to the LPS Diaphyseal Sleeve to the FDA MedWatch Safety Information and Adverse Event Reporting Program.