BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED SHOULDER

    MDR report key: 8723614 · Received June 21, 2019

    Report

    Report Number
    3014128390-2019-00017
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 21, 2019
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K162455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A REVISION SURGERY OCCURRED ((B)(6) 2019) APPROXIMATELY 35 DAYS AFTER THE PRIMARY SURGERY ((B)(6) 2019). ACCORDING TO THE SALES REP, THE PATIENT FELL AND REQUIRED A REVISION OF THE GLENOID COMPONENT. THE EXPLANTED PARTS INCLUDE 36MM CENTERED GLENOSPHERE WITH SCREW (REF: 105-3610), 24MM CEMENTLESS BASEPLATE (REF: 105-0024), AND 36/+6 STANDARD HUMERAL CUP (REF: 103-0806).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517705 HUMELOCK REVERSED SHOULDER REVERSE SHOULDER PROSTHESIS PHX FX SOLUTIONS M2320

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R