FDA-Device2020-09-30Class I

PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component

MicroPort Orthopedics Inc.
Hazard

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.

Sold states
worldwide, except China and Japan
Affected count
556 units
Manufactured in
5677 Airline Rd, N/A, Arlington, TN, United States
Products
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2942-2020

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