BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 9800005 · Received March 6, 2020

    Report

    Report Number
    3009532798-2020-00155
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    March 3, 2020
    Report Date
    March 5, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K162455
    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

    REVISION SURGERY DUE TO A DISLOCATION OCCURRED (B)(6) 2020. 36/+6 HUMERAL CUP WAS REMOVED AND REPLACED BY 36/+9 HUMERAL CUP. THE REASON OF THE DISLOCATION REMAINS UNKNOWN. PRIMARY SURGERY OCCURRED (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266468 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS N0238

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R