BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED SHOULDER

    MDR report key: 8666377 · Received June 4, 2019

    Report

    Report Number
    3014128390-2019-00014
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 30, 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

    THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED APPROXIMATELY 8 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMELOCK REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON UPSIZED THE CUP AND THE GLENOSPHERE. THE ORIGINAL HUMERAL CUP WAS A STANDARD 36/+3 (REF 105-3610). IT WAS REPLACED WITH A STANDARD 40/+9 HUMERAL CUP (REF 104-0809) PLUS A 9MM HUMERAL SPACER (REF 103-0007). THE ORIGINAL GLENOSPHERE WAS A 36MM CENTERED GLENOSPHERE WITH SCREW WITH 10 DEGREE TILT (REF 105-3610), AND IT WAS UPSIZED TO A 40MM CENTERED GLENOSPHERE WITH SCREW WITH 10 DEGREE TILT (REF 105-4010).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459429 HUMELOCK REVERSED SHOULDER REVERSE CONFIGURATION SHOULDER PROSTHESIS PHX FX SOLUTIONS L2334

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R