MicroPort recalls modular neck in THA offering (Healio)
MicroPort Orthopedics Inc. recently announced a class I recall of the modular neck part number PHAC1254 for their PROFEMUR total hip arthroplasty offering.
Initiated on August 7, the recall is in response to reports of an unexpected rate of modular neck fractures following total hip arthroplasty procedures in which the PROFEMUR long cobalt chrome 8° varus/valgus modular neck, part number PHAC1254 was used.
According to the FDA release, “If the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking and performing common task[s]. 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 release noted use and distribution of this product should cease and modular neck PHAC1254 should be shipped to MicroPort’s distribution center in Arlington, Tenn.
The estimated total of devices that need to be recalled is 10,825 in the United States. For further information about the recall, please visit the medical device recall page for this product at the FDA website.
Reference: www.fda.gov.
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