The U.S. Food & Drug Administration (FDA) has issued a Class I recall of Johnson & Johnson’s LPS (Limb Preservation System) Diaphyseal Sleeve, an orthopedic device used in reconstructive knee surgery. According to the FDA, the Sleeve has the potential to fracture at the joint and could result in loss of function, loss of limb, infection, compromised soft tissue or death.
FDA Notifies Healthcare Professionals About DePuy Knee Revision Recall
The FDA notified healthcare professionals about its decision to recall DePuy Orthopaedics’ LPS Diaphyseal Sleeve on February 15, 2013. (DePuy Orthopaedics is a subsidiary of Johnson & Johnson.) The DePuy Class I recall, the most serious type of recall available to the Administration, affects devices manufactured by DePuy from 2008 to July 20, 2012.
Intended for use with the LPS system, the FDA says that the Diaphyseal Sleeve is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The sleeve is supposed to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.
However, the FDA reports that the medical device’s taper connection may not be sufficient to accommodate potential physiologic (normal) loads that may be transferred to the junction during normal gait activities by some patients. In fact, the FDA says that it has received at least 10 reports of the LPS Diaphyseal Sleeve’s malfunctioning – six fractures and four reports of loosening – that may be attributed to the same device design issue.
Medical Device Injury Lawsuits
According to DePuy LPS Diaphyseal Sleeve injury lawyers, this is just the latest in a string of unacceptable and dangerous recalls that could have been avoided. DePuy is currently defending the first of 10,000 product liability lawsuits filed against it over its recalled metal-on-metal hip replacements that have been linked to high failure rates and incidents of metallosis – metal poisoning of the soft tissues.
If you’ve been injured due to a defective medical device, contact The Driscoll Firm, LLC, to discuss your situation and determine whether you might be entitled to compensation in the form of past and future lost wages, pain and suffering and medical expenses.