BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS

    MDR report key: 8666432 · Received June 4, 2019

    Report

    Report Number
    3014128390-2019-00012
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 30, 2019
    Manufacturer
    FX SOLUTIONS
    Product Code
    HSD
    PMA / PMN Number
    K163669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION. THE SURGEON PERFORMED A POLY SWAP APPROXIMATELY 2 MONTHS AFTER THE PRIMARY SURGERY. HE EXPLANTED THE HUMERAL CUP 135/145 STANDARD 36/+6 (REF 313-0706). HE THEN IMPLANTED A STANDARD HUMERAL CUP 36/+6 (REF 103-0806) AS WELL AS A REVERSED ADAPTER 135/145 (REF 112-0100).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460865 HUMERIS CEMENTLESS SHOULDER PROSTHESIS HSD FX SOLUTIONS M0406

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R