BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED

    MDR report key: 10263882 · Received July 13, 2020

    Report

    Report Number
    3009532798-2020-00189
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    March 16, 2020
    Report Date
    July 13, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K162455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT DISLOCATION CAUSED BY REMOVING THE SURGICAL SLING AND REACHING FORWARD. CLOSED REDUCTION PERFORMED IN EMERGENCY ROOM, BUT DISLOCATED AGAIN RESULTING IN 2ND REVISION ON (B)(6) 2020. 36/+9 HUMERAL CUP AND 36MM CENTERED GLENOSPHERE WITH SCREW EXPLANTED - APPEARED UNDAMAGED, ACCORDING TO THE FIELD REPRESENTATIVE. 40/+9 HUMERAL CUP, +9MM SPACER, AND 40MM ECCENTRIC GLENOSPHERE WITH SCREW IMPLANTED. PRIMARY SURGERY OCCURRED IN 2017 (EXACT DATE UNAVAILABLE) AND FIRST REVISION OCCURRED (B)(6) 2020 AND HAS BEEN PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730480 HUMELOCK REVERSED REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS 103-0809 M1406

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R