BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER HUMERAL INSTRUMENT

    MDR report key: 2013277 · Received March 8, 2011

    Report

    Report Number
    1822565-2011-00511
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE HUMERAL PROVISIONAL STEM BECAME STUCK IN THE HUMERAL CANAL. A 1.5 HOUR DELAY IN SURGERY WAS INCURRED. STRESS-RELIEVING HOLES WERE DRILLED AND THE HUMERUS WAS SPLIT IN ORDER TO REMOVE THE PROVISIONAL AND A CERCLAGE CABLE WITH CRIMP WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ZIMMER HUMERAL INSTRUMENT SHOULDER INSTRUMENT KWT ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention