Chinese Device Maker Recalls Hip Component For High Rate Of Fractures

(October 14, 2015, 12:05 PM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on Oct. 2 classified a recall of hip prostheses components by Chinese medical device maker MicroPort Orthopedics Inc. as Class I, meaning that it carries a high risk of serious injury or death.

The FDA said MicroPort has received reports of an “unexpected rate of fractures” after surgery in which the company’s Profemur Neck Varus/Valgus CoCr 8 Degree device was implanted. The agency said that if the modular neck fractures, patients may experience sudden pain, instability and...
To view the full article, register now.