BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-2941-2020 · Reported September 30, 2020

    Enforcement

    Recall Number
    Z-2941-2020
    Event ID
    86153
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroPort Orthopedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2020
    Initiation Date
    July 31, 2020
    Classification Date
    September 18, 2020
    Termination Date
    April 16, 2024
    Address
    5677 Airline Rd, N/A, Arlington, TN, 38002-9501, United States

    Description

    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.

    Code Info

    All lots/serial numbers

    Distribution

    worldwide, except China and Japan

    Quantity

    123,284 units