MicroPort Orthopedics Inc. recalls PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206
Recalled Product
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
Hazard / Issue
MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.
Issued by
FDA
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