BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 4822782 · Received June 6, 2015

    Report

    Report Number
    3010536692-2015-01277
    Event Type
    Injury
    Date Received
    June 6, 2015
    Date of Event
    February 25, 2011
    Report Date
    May 7, 2015
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED WHEN INVESTIGATION COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2015-01276.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE BROKEN NECK- RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366423 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. 106379975

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention