BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS

    MDR report key: 10315211 · Received July 23, 2020

    Report

    Report Number
    3014128390-2020-00043
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    June 25, 2020
    Report Date
    July 23, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT REVISED ON (B)(6) 2020 10 DAYS AFTER THE PRIMARY SURGERY. SURGEON EXPLANTED 135/145 36/+9 STANDARD HUMERAL CUP AND IMPLANTED A NEW 135/145 36/+9 STANDARD HUMERAL CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776389 HUMERIS REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS M1421

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O| R