BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR MODULAR FEMORAL NECK

    MDR report key: 10230312 · Received July 3, 2020

    Report

    Report Number
    3010536692-2020-00466
    Event Type
    Injury
    Date Received
    July 3, 2020
    Report Date
    July 3, 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 · 1

    (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PROSTHESIS DISLOCATION COMPONENT NOT REVISED: COTYLE "ANCA" AVEC TROUS A/REVET. HAP 46, PPR67246, LOT: R0793475.3. TIGE "ANCA FIT?" REV. HAP 1/3 PROXIMAL 11D, PPR67604, LOT: R1097252<1 INSERT CERAM "ANCA FIT?" 28/37 46-48/28 AL2.O3 BIOLOX FORTE, PPR67508, LOT: S01100847X1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691710 PROFEMUR MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01202 SO2102564 M684PHA012021

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R