BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IM POST

    MDR report key: 2200751 · Received July 26, 2011

    Report

    Report Number
    3005751028-2011-00057
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ZIMMER TMT
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RETURNED INSTRUMENT VERIFIED THE CONDITION OF THE INSTRUMENT. THE CONDITION OF THE INSTRUMENT INDICATES THAT A SIDE BENDING LOAD WAS GENERATED, WHICH IS INCONSISTENT WITH THE DESIGN INTENT. BUT BASED ON THE INVESTIGATION, THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE AFFECT TO THE PT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROD THAT SCREWS IN TO THE LCCK STEM EXTENSIONS BROKE OFF AT THE THREADS/SHAFT JUNCTION DURING BROACHING. THIS MADE IT DIFFICULT TO REMOVE THE STEM TRIAL DUE TO THE THREADED PORTION OF THE IM SHAFT BEING STUCK IN THE STEM. THE STEM WAS REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IM POST IM POST HSB ZIMMER TMT 61786516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention