Class 1 Recall Issued for MicroPort Hip Implant Component
October 16th, 2015 by Cutter Law
The FDA has issued a Class 1 recall of the MicroPort Profemur modular neck device, part of a metal hip replacement system.
The device (the Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254) is being recalled because:
“MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to this specific modular neck. If the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking and performing common task. An acute fracture will require revision surgery to remove and replace the neck and stem components. Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, and even death.”
The parts were manufactured from June 15, 2009 to July 22, 2015 and distributed from the same start date to July 31, 2015. In the US, over 10,000 of the units have been recalled.
The recall states that “patients should seek immediate medical treatment if they experience any sudden onset of severe pain in their post-operative hip, difficulty or inability walking, significant trauma to their hip or leg (e.g. falling), or a tingling sensation or loss of feeling in their leg”.
According to the FDA, “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
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