BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTECH

    MDR report key: 11892151 · Received May 27, 2021

    Report

    Report Number
    3009532798-2021-00055
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 17, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    HSD
    UDI-DI
    03701037300404
    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 (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 DISLOCATION APPROXIMATELY 2 YEARS AFTER THE PRIMARY SURGERY. THE PRIMAR SURGERY USED THE EASYTECH ANATOMICAL SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE 43 X 16 CENTERED HEAD AND THE +0MM DOUBLE TAPER. IT WAS REPLACED BY A REVERSED CONFIGURATION. THE SURGEON IMPLANTED A Ø24 BASEPLATE, A Ø36 CENTERED GLENOSPHERE, A Ø36/+3 135/145 HUMERAL CUP AND ASSOCIATED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788569 EASYTECH SHOUDLER PROSTHESIS HSD FX SOLUTIONS DIAMETER 43 mm CENTERED M1823 03701037300404

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R