On February 22, 2013, the FDA announced a Class 1 Recall of the DePuy LPS Diaphyseal Sleeve. The agency urged healthcare professionals and hospitals to immediately stop distributing or using the recalled lots, which include those manufactured from 2008 to July 20, 2012.
The LPS Diaphyseal Sleeve is used with the company’s LPS knee replacement system, and has been reported to malfunction in some patients, causing fracture of the sleeve which can also lead to compromised or death of soft tissue, infection, and even loss of function or loss of the limb.
DePuy Orthopaedics is currently facing more than 10,000 lawsuits filed in courts around the country concerning its hip replacement devices”the ASR and the Pinnacle”which have been linked to complications including pain, immobility, premature loosening, metal contamination, and early implant failure.
What is the LPS Diaphyseal Sleeve?
The DePuy LPS Diaphyseal Sleeve is used during reconstructive knee surgery in patients who have severe soft tissue damage or bony defects. The sleeve itself is cone-shaped, and intended to œenhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements, according to the FDA.
The problem with the sleeve is that it may not be able to sufficiently bear a patient’s weight during normal activities like walking. That means it could fracture, which can then lead to other complications like damage or death of soft tissue.
FDA Receives Reports of LPS Diaphyseal Sleeve Defects
So far, the FDA says that they have received a total of 10 reports of incidents in which the LPS Diaphyseal Sleeve malfunctioned. In six of those cases, patients suffered a fracture of the component and in the remaining four patients experienced a loosening that may or may not be related to the same design issue.
œClass I recalls are the most serious type of recall, the FDA stated, œand involve situations in which there is reasonable probability that use of these products will cause serious adverse health consequences or death.
Next Steps for Patients and Doctors
The FDA noted that DePuy Orthopaedics, a subsidiary of Johnson & Johnson, first issued an Urgent Medical Device Recall on January 4, 2013, warning hospitals and surgeons to immediately stop distributing or using the recalled lots. They add that if a medical facility has the affected products in stock, they should immediately return them to DePuy.
Neither DePuy nor the FDA has recommended any action in patients that don’t have symptoms. DePuy has advised doctors, however, to discuss the recall with patients, and to make them aware of potential symptoms that may occur if the device malfunctions.
DePuy Knee Implant Lawyer Can Help
If you were implanted with a DePuy LPS knee replacement system and you experienced symptoms such as infection, loosening, fracture, soft tissue damage, or worse, you may be eligible to file a DePuy LPS Diaphyseal Sleeve lawsuit.
Chaffin Luhana LLP has years of experience defending victims in personal injury lawsuits, and will work aggressively to help you obtain the compensation you deserve. Call today for a free and confidential case evaluation at 1-888-480-1123.