BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ROTATING HINGE KNEE SCREW DRIVER

    MDR report key: 1990979 · Received February 10, 2011

    Report

    Report Number
    1822565-2011-00220
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    BREAKAGE & STRONG DAMAGE OF SCREW DRIVERS IS REPORTED: SURGERY HAD TO BE ABORTED AS THE IMPLANT COULD NOT BE REMOVED WITH THESE INSTRUMENTS. SURGERY WAS POSTPONED FOR 12 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ROTATING HINGE KNEE SCREW DRIVER LXH ZIMMER INC 60537406

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LOT #UNK| SCREW DRIVER| NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE| CATALOG #00588102600