BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION HEX DRIVER BIT FOR TIBIAL COMPONENT ASSEMBLY

    MDR report key: 1586924 · Received January 15, 2010

    Report

    Report Number
    1822565-2010-00030
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 21, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    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

    IT IS REPORTED THAT TWO HEX DRIVER BITS (NEW AND UNUSED) BROKE WHEN THE RHK VERTICAL AXIS WAS TRIED TO BE LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION HEX DRIVER BIT FOR TIBIAL COMPONENT ASSEMBLY KNEE INSTRUMENT LXH ZIMMER, INC. NA 61150808

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE| SCREW DRIVER, LOT# 60633103| CATALOG #00588102600