Diaphyseal Sleeve FAQ

The DePuy LPS Diaphyseal Sleeve is a medical device. It allows surgeons to reconstruct severe soft tissue and bone defects found as they perform knee reconstruction surgery. “LPS” in the device’s name stands for “limb preservation system.” The diaphysis is the midsection of a long bone. A diaphyseal sleeve is inserted to support the diaphyseal femoral canal (an interior portion of the leg bone) in procedures that require reconstruction of parts of the femur and tibia.

The LPS Diaphyseal Sleeve is a product of DePuy Orthopaedics, Inc. of Warsaw, Indiana. DePuy was established in 1895 as the first commercial orthopedics company in the U.S. Today, it is a subsidiary of Johnson & Johnson.

In some patients, the DePuy LPS Diaphyseal Sleeve breaks, or fractures, when the patient puts their full weight on the leg that contains the device and walks.

The U.S. Food and Drug Administration (FDA) says it has received a total of 10 reports about the DePuy LPS Diaphyseal Sleeve’s malfunctioning. They include six reports of the sleeve’s fracturing and four reports of its loosening, which may or may not be attributed to the same device design issue that causes fractures, the FDA says.

The FDA has warned that fracture of the DePuy LPS Diaphyseal Sleeve may lead to infection, compromised soft tissue, loss of function or loss (amputation) of the affected limb and possibly death.

Yes, DePuy Orthopaedics, Inc. and the FDA separately issued a recall notice for the DePuy LPS Diaphyseal Sleeve in January and February 2013, respectively. The FDA’s recall was a Class I recall. The agency says this type of recall is reserved for “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” The recall order is for all unused DePuy LPS Diaphyseal Sleeves to be returned to the manufacturer.

Technically, the DePuy LPS Diaphyseal Sleeve recall, as issued by DePuy Orthopaedics, Inc., and the FDA’s Class I recall do not affect sleeves already implanted in patients.

The order calls for hospitals and surgeons to immediately stop distributing or using the recalled devices and to return any they have in stock to DePuy. The manufacturer is not recommending revision surgery or any additional follow-up with patients who have already received the sleeve in the absence of symptoms that the device has failed. According to the FDA, DePuy is “encouraging surgeons to communicate with patients” about the problems with the DePuy LPS Diaphyseal Sleeve and to instruct patients on how to recognize problems if they occur.

Fortunately, at this time, there are no published reports of death attributed to the failure of a DePuy LPS Diaphyseal Sleeve implanted during knee reconstruction surgery.

If you or a family member of yours has been implanted with a DePuy LPS Diaphyseal Sleeve during knee reconstruction surgery, you should contact a personal injury attorney who has successfully pursued cases on behalf of people injured by faulty medical devices and dangerous pharmaceuticals. Next, you should contact the surgeon who implanted the device and request copies of all medical records pertaining to it.

An initial consultation with a DePuy LPS Diaphyseal Sleeve injury lawyer at The Driscoll Firm, LLC, is free and confidential. If The Driscoll Firm believes you have a valid claim and you choose to pursue it, further legal work on your behalf will be done on a contingency-fee basis. This means you will not be charged a legal fee until we obtain a monetary settlement or court-ordered award for you. Even then, the fee will be based on a nominal percentage of the final award or settlement in your case.

You should consult these FDA notices:

• DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall
• Medical Devices Recall – DePuy Orthopaedics, Inc. – LPS Diaphyseal Sleeve

You should also contact The Driscoll Firm, LLC, at our toll-free number or through our online form to speak with a DePuy LPS Diaphyseal Sleeve injury lawyer.