BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 10351265 · Received July 31, 2020

    Report

    Report Number
    3010536692-2020-00536
    Event Type
    Injury
    Date Received
    July 31, 2020
    Report Date
    July 31, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    UDI-DI
    M684PHA012521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COMPONENTS NOT REVISED: PPR67614 TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 13G T07125201M PPR67254 COTYLE "ANCA" AVEC TROUS A/REVET. HAP 54 T06123349.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814303 PROFEMUR MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01252 T11134782 M684PHA012521

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention