Profemur Modular Neck Recall Issued Due to High Hip Implant Failure Rate
An unexpectedly high rate of hip implant fractures has led to the recall of nearly 11,000 Profemur Varus/Valgus modular neck components for artificial hip replacement systems.
The FDA announced the Profemur hip recall for the Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck on October 2, indicating that it is a Class I medical device recall.
The manufacturer, MicroPort Orthopedics Inc., has received an unexpectedly high number of reports of the Profemur hip implant components fracturing after surgery, which can result in sudden pain, problems walking and instability.
The Class I recall designation means that the FDA believes that these implants pose a reasonable probability of causing a serious injury or death, which is the most serious classification that can be attached to a medical device recall.
“An acute fracture will require revision surgery to remove and replace the neck and stem components,” the FDA warned. “Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, and even death.”
MicroPort first informed distributors and hospitals about the recall on August 7. The recall affects all lots of the PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254. The parts were manufactured from June 15, 2009 to July 22, 2015, and distributed from June 15, 2009, through July 31, 2015. An estimated 10,825 devices are affected by the recall.
In August 2013, MicroPort began manufacturing the Profemur hip implant when it acquired Wright Medical Group’s OrthoRecon business. However, prior to that purchase, similar problems with Profemur femoral necks were reported, where patients experienced a catastrophic implant failure when the modular femoral neck fractured or broke.
A number of Profemur hip lawsuits were filed over design defects associated with the implant, most of which were settled by Wright Medical Group in late 2013 or early 2014.
In this new recall for Profemur modular neck stems, MicroPort has asked distributors and hospitals to review the notification and make sure affected personnel are aware of it. They also want the parts located and distribution and use of the modular neck’s ceased.
For patients who have already had one of the recalled Profemur hip components implanted, the manufacturer indicates that they should seek medical treatment immediately if they experience any sudden severe pain in a post-operative implant, or if they experience difficulty or inability walking or a tingling feeling or loss of feeling in their leg.
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