BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK II SHOULDER SYSTEM

    MDR report key: 8813875 · Received July 22, 2019

    Report

    Report Number
    3014128390-2019-00023
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 22, 2019
    Manufacturer
    FX SOLUTIONS
    Product Code
    HSD
    PMA / PMN Number
    K123814
    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 APPROXIMATELY 11 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT DISLOCATED, AND THE SURGEON PERFORMED A POLY SWAP. HE EXPLANTED THE 40/+3 135/145 HUMERAL CUP (REF 314-0703), AND HE REPLACED IT WITH A LARGER HUMERAL CUP (40/+9 135/145 HUMERAL CUP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604076 HUMELOCK II SHOULDER SYSTEM SHOULDER PROSTHESIS HSD FX SOLUTIONS I1249

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R