BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFEMUR(R) THREADED STEM INSERTER***

    MDR report key: 3783745 · Received May 1, 2014

    Report

    Report Number
    3010536692-2014-00722
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY THE SURGEON HAS BROKEN THE TIP OFF OF 1. REP DOESN'T BELIEVE IT IS A DESIGN / QUALITY ISSUE BECAUSE THE SURGEON IS A HIGH USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262144 PROFEMUR(R) THREADED STEM INSERTER*** HIP INSTRUMENT LXH MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1