DePuy recall lawyers at Pintas & Mullins Law Firm report that the Johnson & Johnson subsidiary recently announced yet another recall of its intercalary component due to premature fractures and required revision surgeries. The recalled product is the Limb Preservation System (LPS) Lower Extremity Dovetail Intercalary Component.
The FDA initiated the class 1 recall – the most serious of recalls extended only to drugs and medical devices that involve a reasonable probability to cause serious injury or death – for the LPS Component on August 1, 2013. Less than one month before that, DePuy issued an Urgent Medical Device Recall informing distributors, surgeons and hospitals of the devices’ severe problems. In its urgent notification, DePuy provided a template for surgeons and hospitals to send patients implanted with this specific device intended to inform them of the risks of implant fracture and methods for detecting such a fracture.
The LPS Lower Extremity Dovetail Intercalary component is intended for patients who require mid-shaft, top, bottom, and/or total femur replacements, top tibia replacements, and extensive limb resection surgeries after tumors, trauma, or infections. The FDA confirms that the dovetail component of this device may fracture when exposed to normal, commonplace physiologic loads while walking or performing other daily activities.
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Dovetail fractures may lead to additional pain around the implant site, loss of leg function, serious infection, neurovascular injury, loss of limb, or, ultimately, the need for revision surgery, which is often much more painful than the original implantation surgery. Patients weighing over 200 pounds and those engaging in high levels of physical activity are at higher risk of these fractures and side effects.
These LPS devices were distributed between February 2007 and May 2013, and the lot numbers subject to the recall can be found on the FDA’s website. Any adverse reactions or quality problems experienced from the LPS can be reported to the agency’s MedWatch Safety Information Program, located here.
The LPS Component includes four separate parts: two cylinders, one called the dovetail (what the company refers to as the ‘female’ part), which interlock to replace the femur bone, and two pins that insert into the joints to lock them in place. The FDA is also investigating DePuy’s LPS Diaphyseal Knee Sleeve systems due to similar concerns of serious side effects. An increasing number of patients implanted with this knee system have reported adverse events from the DePuy device.
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The Knee Sleeve was recalled earlier this year, in February 2013, over life-threatening problems associated with – you guessed it – fractures at the sleeve’s taper joint. This caused total loss of knee function, loss of limb, infections, compromised soft tissue, and tissue death. According to the FDA, not all patients implanted with this device are aware it was recalled, and even fewer are aware that they can report their adverse side effects directly to the agency (through the MedWatch program, linked to above).
Like the Lower Extremity device, the Knee Sleeve joint connections are not sufficient to accommodate potential physiologic loads being transferred during normal gait activities, particularly by patients engaging in high physical activity or who are overweight. Some of the more common adverse events associated with the knee device include shifting of the components, bending, fatigue fractures, dislocations, loosening, cracking, tissue reaction, infection, decreased range of motion, and loss of limb.
DePuy and its extensive line to medical device implants have been subject to mounting litigation in recent years due to their defective designs and poor testing practices. There are thousands of cases currently pending, for example, concerning injuries from the company’s metal-on-metal hip devices, for which we are already representing many clients.
DePuy Orthopedics recall attorneys at Pintas & Mullins Law Firm will do everything we can do ensure the process of filing a lawsuit and obtaining compensation is as quick and easy as possible. If you or a loved one received a DePuy medical device implant and suffered serious injuries, contact a qualified attorney as soon as possible for a free legal evaluation.