BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERIS REVERSED

    MDR report key: 11892133 · Received May 27, 2021

    Report

    Report Number
    3009532798-2021-00063
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    March 30, 2021
    Report Date
    May 17, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    UDI-DI
    03701037300237
    PMA / PMN Number
    K150488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (IN (B)(6)) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET WITHIN THE UNITED STATES.

    Description of Event or Problem · 1

    THE EVENT WAS A REVISION SURGERY DUE TO THE GLENOSPHERE LOOSENING THAT OCCURED APPROXIMATELY 3 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. THE SURGEON EXPLANTED THE 36/+3 135/145 HUMERAL CUP, THE 36 CENTERED GLENOSPHERE, THE 24 BASEPLATE, THE +10MM POST EXTENSION AND ASSOCIATED SCREWS. THEN HE IMPLANTED A 40/+6 135/145 HUMERAL CUP, A 40 CENTERED GLENOSPHERE, A +10MM POST EXTENSION, A 24 BASEPLATE AND ASSOCIATED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794753 HUMERIS REVERSED REVERSE SHOULDER PROSTHESIS PHX FX SOLUTIONS UNIQUE SIZE P0872 03701037300237

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R