BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK

    MDR report key: 11641750 · Received April 9, 2021

    Report

    Report Number
    3009532798-2021-00042
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    February 24, 2021
    Report Date
    April 7, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    HSD
    UDI-DI
    03701037300381
    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

    THE EVENT WAS A REVISION SURGERY DUE TO A FAILURE OF THE ROTATOR CUFF APPROXIMATELY 5 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE EASYTECH ANATOMICAL SYSTEM, THE REVISION SURGERY IS USING THE HUMELOCK REVERSED SYSTEM. THE SURGEON EXPLANTED THE +0 DOUBLE TAPER, THE XS ANATOMICAL GLENOID, THE Ø39 CENTERED HEAD AND THE Ø34 ANCHOR BASE. HE IMPLANTED A CEMENTED METAPHYSIS Ø32 STEM, A Ø24 BASEPLATE, A Ø36 CENTERED GLENOSPHERE, Ø36 HUMERAL CUP, A 10MM POST EXTENSION AND ASSOCIATED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539333 HUMELOCK SHOULDER PROSTHESIS HSD FX SOLUTIONS DIAMETER 39 mm CENTERED N0342 03701037300381

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R