The U.S. Food and Drug Administration (FDA) has notified healthcare providers that DePuy Orthopaedics has issued a Class I recall of its LPS Disphyseal Sleeve orthopedic knee device due to a potential for fracture of the device.
The device, called the LPS Diaphyseal Sleeve, is used to create a better fit and feel for patients receiving knee replacement with the company’s LPS System.
“The LPS Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients,” the February 22nd announcement says. “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.”
The FDA did not report any deaths from the product.
The sleeve is intended for use with the LPS System, which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve enhances the fit of the diaphyseal femoral canal with femoral and tibial replacements.
At issue were the devices, which were manufactured from 2008 to July 20, 2012, according to the announcement. On January 4th, Johnson & Johnson affiliate, DePuy Orthopaedics Inc., issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and warned them to immediately stop distributing or using the recalled product. The company said they would take back any unused stock from medical facilities.
“DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device,” the FDA announcement says. “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 symptoms.”
The FDA is encouraging healthcare professionals and patients to report adverse events or side effects related to the use of the device to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at http://www.fda.gov/Safety/MedWatch/default.htm
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