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DePuy Orthopaedics issues Class I recall of LPS Diaphyseal Sleeve from Artificial Knee

By Burg Simpson
February 25, 2013
2 min read

The U.S. Food & Drug Administration has announced the DePuy Orthopaedics is recalling the Limb Preservation System (“LPS”) Diasphyseal Sleeve used in artificial knee replacement surgery.  The reason for the recall is that the Sleeve Base taper connection may not be strong enough to handle the stress of normal activities in some patients, resulting in a fracture of the sleeve at the taper joint.  The FDA has received a total of 10 reports of incidents in which the device has malfunctioned. Failure of the device can cause loss of function or loss of the limb, infection or death.  The affected devices were manufactured from 2008 to July 20, 2012.

FDA Safety Alert for DePuy LPS Diaphyseal Sleeve 2/22/13

FDA Recall Notice for DePuy LPS Diaphyseal Sleeve 2/22/13

On January 4, 2013, Depuy issued an Urgent Medical Device Recall informing hospitals and doctors of the problem and to immediately stop using the recalled lots.  DePuy is not recommending revision or additional follow-up in the absence of symptoms for patients with the implanted device.  However, DePuy is encouraging doctors to inform their patients of the issue and discuss the risks of implant fracture and the method for detecting implant failure if the patient begins to have symptoms.

The attorneys at Burg Simpson are experienced in litigation involving medical devices, and in the complex medical and legal issues concerning injuries caused by defective medical devices.  If you or a loved one have suffered injury due to the use of a medical device, please contact us for a confidential consultation.  Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

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