BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDER SOLUTIONS NATURAL KNEE FLEX SYSTEM FEMORAL SIZER

    MDR report key: 1243162 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00832
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 IS REPORTED THAT DR. ATTEMPTED TO PUT THE LEFT FEMORAL PROVISIONAL OF THE PT TO TRIAL THE KNEE. THE CUTS ACCURATELY FIT THE PROVISIONAL, BUT THE FEMORAL DRILLED LUG HOLES DID NOT MATCH UP TO THE FEMORAL TRIAL PROVISIONAL. THE FEMORAL PROVISIONAL LUGS WERE POSTERIOR TO THE DRILLED LUG HOLES BY ABOUT 1-2MM. DR. PROCEEDED TO USE THE PROVISIONAL TO CREATE THE PROPER LUG HOLES THAT MATCHED THE RESURFACED FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDER SOLUTIONS NATURAL KNEE FLEX SYSTEM FEMORAL SIZER KNEE INSTRUMENT LXH ZIMMER, INC. NA 60898448

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK