BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 10460349 · Received August 27, 2020

    Report

    Report Number
    3010536692-2020-00590
    Event Type
    Injury
    Date Received
    August 27, 2020
    Report Date
    August 27, 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 PAIN WITHOUT LOOSENING COMPONENTS NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 50, PPR67250, LOT V0288744. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 14D, PPR67616, LOT V04185939. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, PPR67510, LOT U10129286.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925045 PROFEMUR MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01252 V06201722 M684PHA012521

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention