Recall Z-2941-2020— MicroPort Orthopedics Inc.

Name: FDA recall Z-2941-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-31

Class I · Terminated

Class I FDA medical device recall by MicroPort Orthopedics Inc., initiated 2020-07-31, terminated 2024-04-16. It names one FDA 510(k) clearance: K003016. Product: PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.. Reason: 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..

Recalling firm: MicroPort Orthopedics Inc.
Classification: Class I
Status: Terminated
Initiated: 2020-07-31
Terminated: 2024-04-16
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K003016 — PRO-FEMUR RWrightmedicaltechnologyinc·cleared 2000-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.