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FDA Announces DePuy LPS Diaphyseal Sleeve Recall

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Over 10,000 patients who have experienced complications with DePuy Orthopaedic’s hip implant products are now seeking lawsuit settlements or jury awards to help compensate them for their medical expenses, lost wages, pain, and suffering. Now, we may see even more coming forward with similar complaints—this time, concerning DePuy’s LPS knee implant system.

On January 4, 2013, the company issued an Urgent Medical Device Recall to hospitals and surgeons, warning them to immediately stop using certain lots of the DePuy LPS Diaphyseal Sleeve, a component of the LPS knee implant system. The FDA followed up on February 22, 2013, with a Class I recall of the device, after 10 patients reported serious complications.

Problems Occurring with One Component of LPS Knee System

Orthopedic surgeons use the LPS Diaphyseal Sleeve during knee reconstruction surgery on patients who have suffered severe soft tissue damage, bone loss, and/or bone deformity. The bone loss may have occurred because of a tumor, multiple arthroplasty procedures, infection, or severe trauma.

The "limp preservation system (LPS)" as a whole offers a variety of component options for the surgeon when performing knee reconstruction surgery, including diaphyseal sleeves, which are used to enhance the fit of the knee replacement with the patient’s femur, or thigh bone. Cone-shaped, the sleeve is implanted along the shaft of the femur.

Recent reports, however, have indicated that in some cases, the taper connection may not be strong enough to withstand the patient’s weight during normal wear and tear. Under certain conditions, the component can buckle and fracture, causing serious complications.

Patients Suffer Fractures with the Diaphyseal Sleeve

According to the FDA, they’ve received 10 reports of complications related to the DePuy Diaphyseal Sleeve. In six of those reports, the malfunctioning sleeve fractured. Such fractures can lead to infection, soft tissue damage and death, loss of function, or even loss of the limb.

The other four reports involved premature loosening of the implant, which may or may not be related to the Diaphyseal Sleeve. The FDA issued the Class I recall, however, because of concern of serious side effects. "Class I recalls are the most serious type of recall," the agency stated, "and involve situations in which there is reasonable probability that use of these products will cause serious adverse health consequences or death."

Watchful Waiting for Patients with the Device

Both the FDA and DePuy have advised doctors and hospitals to return any Diaphyseal Sleeves manufactured between 2008 and July 20, 2012 that they may still have in their possession. For those patients who have already been implanted with the device, however, DePuy recommends watchful waiting.

"DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device," the FDA stated in their recall announcement. "However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms."

Meanwhile, doctors and patients are encouraged to report any problems related to the use of the component to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.