FDA: Class I recall of PROFEMUR modular neck prostheses

Editor's Note

The Food and Drug Administration on October 2 categorized the recall of PROFEMUR Neck Varus/Valgus CoCr 8 degree, Part number PHAC 1254, by MicroPort Orthopedics as Class I, the most serious.

The company has received reports of unexpected fractures after surgery related to this modular neck. If the neck fractures, the patient may experience sudden pain, instability, and difficulty walking. The neck and stem components will have to be replaced.

Acute fracture and emergency revision surgery could lead to neurovascular damage, hematoma, hemorrhage, and even death.

Posted 10/02/2015] AUDIENCE: Risk Manager, Orthopedics ISSUE: 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.