Friday, August 9, 2013

DePuy Hip Class I Recall Announced By FDA of Its DePuy LPS Lower Extremity Dovetail Intercalary Hip Implant Component Due to Risk of Fracturing

Wright Schulte
The Food and Drug Administration (FDA) has recently announced that DePuy Orthopaedics, Inc. has issued an Urgent Medical Device Recall for one of its popular hip implant components, the LPS Lower Extremity Dovetail Intercalary component. This DePuy recall has been issued due to the component’s propensity to fracture. While DePuy issued its recall of this component on July 11, 2013, as of August 1, 2013, the FDA elevated this DePuy recall to a Class I recall status – the most serious type of recall that can be issued – due to the likelihood of alleged serious injury or death associated with these malfunctioning DePuy hip implant components.

According to the FDA’s DePuy recall announcement, the recalled LPS hip implant component can fracture under “normal physiologic loads while walking.” This means that it does not take a lot of weight on these components in order to increase the likelihood that they will break. Patients with the highest risk of experiencing an LPS hip implant fracture include those who weigh more than 200 pounds and/or who are highly active individuals.

In the event that the LPS Lower Extremity Dovetail Intercalary component does fracture, patients will likely experience severe hip pain and immediate loss of hip function. In most cases of the component fracturing, patients will need to undergo risky revision surgery to remove the broken component. Additionally, patients who experience a component fracture will typically also suffer from serious nerve injuries and may even lose the leg connected to the fractured device.


Read more: http://www.digitaljournal.com/pr/1395480#ixzz2bT6dC5EU

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