BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK II REVERSED

    MDR report key: 11892145 · Received May 27, 2021

    Report

    Report Number
    3009532798-2021-00054
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    March 19, 2021
    Report Date
    May 7, 2021
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    UDI-DI
    03701037301364
    PMA / PMN Number
    K150488
    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 DISLOCATION THAT OCCURED APPROXIMATELY 1 MONTH AFTER THE PRIMARY SURGERY. THE PRIMAR SURGERY USED THE HUMELOCK II REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø36 CENTERED GLENOSHERE AND THE 135/145 Ø36/+6 HUMERAL CUP. THEN HE IMPLANTED Ø40 ECCENTRIC GLENOSHERE AND A 135/145 Ø40/+9 HUMERAL CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788568 HUMELOCK II REVERSED REVERSED SHOULDER PROSTHESIS PHX FX SOLUTIONS DIAMETER 36+6 L2757 03701037301364

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R