BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMELOCK REVERSED SURGICAL INSTRUMENT

    MDR report key: 8772778 · Received July 9, 2019

    Report

    Report Number
    3014128390-2019-00020
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 9, 2019
    Manufacturer
    FX SOLUTIONS
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING A REVISION SURGERY, THE IMPACTOR FROM THE REVERSED GLENOID SURGICAL INSTRUMENT SET (REF 604-0008) BECAME STUCK IN THE HUMERAL SPACER. IN THE PROCESS OF UNSTICKING THE INSTRUMENT, THE HUMERAL STEM CAME OUT. THIS DELAYED THE SURGERY BY AROUND 30 MINUTES, ACCORDING TO THE FIELD REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564821 HUMELOCK REVERSED SURGICAL INSTRUMENT REVERSE SHOULDER PROSTHESIS SURGICAL INSTRUMENTS LXH FX SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization