BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION FLEXION BALANCING INTRUMENTATION FEMORAL ANTERIOR/

    MDR report key: 1003761 · Received February 22, 2008

    Report

    Report Number
    1822565-2008-00064
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY WHEN MAKING THE PRELIMINARY ANTERIOR AND POSTERIOR FEMORAL CUTS WITH THE FBI A/P CUT GUIDE, SIZE C AND THEN LATER DECIDING TO UP-SIZE TO A D. WHEN THEY USED THE SIZE D MIS FEMORAL FINISHING GUIDE, THERE WAS NO BONE AVAILABLE TO MAKE THE FINAL POSTERIOR CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION FLEXION BALANCING INTRUMENTATION FEMORAL ANTERIOR/ KNEE INSTRUMENT KWY ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK