Knee Implant Device Recall

 Posted on April 24,2013 in Defective Medical Devices

As if Johnson & Johnson didn't have enough problems with their hip implant device Articular Surface Replacement (ASR), now the U.S. Food and Drug Administration (FDA) has announced a Class I recall for another orthopedic device made by the manufacturer – LPS Diaphyseal Sleeve. The device is used in reconstructive knee surgeries and is being recalled because of the potential for fractures that the device poses.

A Class I recall is the most serious recall that the FDA can issue and typically involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. In its announcement, the FDA said fractures of the device that occur at the taper joint of the sleeve could cause soft tissue to become compromised and result in infection, function loss, limb loss, or death.

The FDA has received ten reports of the product malfunctioning. Reports included six fractures and 4 incidents where the product loosened up. DePuy, Johnson & Johnson's orthopedic medical device division, and makers of both this device and the ARS, has issued an Urgent Medical Device Recall to healthcare providers to stop using the recalled units immediately and return unused devises to DePuy.

The company is not advising revisions with patients that already have this implanted device, but did recommend that doctors warn those of the risks and detections of problems.

If you have had problems with this device, or any other recalled device, you should consult with an experienced Illinois defective medical device attorney to find out what civil action may be taken against the manufacturer.