BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 10254687 · Received July 9, 2020

    Report

    Report Number
    3010536692-2020-00474
    Event Type
    Injury
    Date Received
    July 9, 2020
    Report Date
    July 10, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    UDI-DI
    M684PHA012021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION CODES UPDATED. - ATTACHMENT: [19070913FDATIMINGLETTERUPDATES.PDF].

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED. EVALUATION CODES ADDED.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION. COMPONENT NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 50, PPR67250, LOT U0668551. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 12D, PPR67608, LOT T11129538. INSERT CERAM "ANCA FIT?" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, PPR67510, LOT U09112683.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716882 PROFEMUR MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01202 U0988869 M684PHA012021

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R