BEUDAMED
    FDA Adverse Event Summary report: N

    K3 FLEX

    MDR report key: 1081145 · Received July 11, 2008

    Report

    Report Number
    1081145
    Date Received
    July 11, 2008
    Date of Event
    February 8, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    HRS
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    LEFT TIBIAL BASE PLATE SIZE 2 SIZER HAD POSSIBLE METAL BURRS THAT SCRATCHED THE DRILL BIT AND LEFT METAL SHAVINGS IN THE LEFT KNEE. SHAVINGS REMOVED PER SURGEON AND IRRIGATED WITH ANTIBIOTIC SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K3 FLEX HARDWARE, ORTHOPEDIC, BASEPLATE, TOTAL KNEE HRS ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR