Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2941-2020 — PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.

U.S. FDA — Device Enforcement · United States · 2020-07-31 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2941-2020
Date of alert
2020-07-31
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
MicroPort Orthopedics Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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