BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 9904112 · Received March 31, 2020

    Report

    Report Number
    3010536692-2020-00297
    Event Type
    Injury
    Date Received
    March 31, 2020
    Report Date
    March 31, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    UDI-DI
    M684PHA012541
    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: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 54 PPR67254, LOT T07124541. TETE FEMORALE 28 CM 12/14 CERAMIQUE AL2.O3 PPT10252, LOT T10133573. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 12G PPR67610, LOT T07126076. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE PPR67510, LOT T09133022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367195 PROFEMUR MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01254 S12118637 M684PHA012541

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention