BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® MODULAR FEMORAL NECK

    MDR report key: 9676308 · Received February 6, 2020

    Report

    Report Number
    3010536692-2019-00930
    Event Type
    Injury
    Date Received
    February 6, 2020
    Report Date
    July 31, 2019
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF INSERT, HEAD AND NECK. COMPONENTS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 54 PPR67254 LOT R0589526.1, TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 14D PPR67616 LOT R0591057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140728 PROFEMUR® MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01202 R0693889

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention