BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTECH

    MDR report key: 11946174 · Received June 7, 2021

    Report

    Report Number
    3009532798-2021-00092
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 7, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    HSD
    PMA / PMN Number
    K111097
    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 A DISLOCATION OCCURRED (B)(6) 2021. THE DISLOCATION HAPPENED DUE TO FALSE MOVEMENT MADE BY THE PHYSIO DURING A REHABILITATION SESSION. Ø39 HUMERAL HEAD AND DOUBLE TAPPER WERE REMOVED AND REPLACED BY Ø39 HUMERAL HEAD AND Ø39+3 CENTERED SPACED. PRIMARY SURGERY OCCURRED (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841454 EASYTECH SHOULDER PROTHESIS HSD FX SOLUTIONS N0360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R