BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK II

    MDR report key: 10441747 · Received August 24, 2020

    Report

    Report Number
    3009532798-2020-00348
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 24, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K123814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INSTABILITY OCCURRED (B)(6) 2020. 36/+3 HUMERAL CUP AND 36 CENTERED GLENOSPHERE WITH SCREW WERE REMOVED AND REPLACED BY 40/+3 STABILITY HUMERAL CUP AND 40 CENTERED GLENOSPHERE WITH SCREW. PRIMARY SURGERY ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910421 HUMELOCK II REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS 105-3610 L1845A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R