BEUDAMED
    FDA Adverse Event Summary report: N

    MY KNEE FEMUR CUTTING BLOCK #5 RIGHT MEDIAL

    MDR report key: 3718461 · Received February 21, 2014

    Report

    Report Number
    3006639916-2014-00015
    Date Received
    February 21, 2014
    Date of Event
    January 20, 2014
    Report Date
    February 21, 2014
    Manufacturer
    MEDACTA USA INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    MY KNEE FEMORAL DOWNSIZE: AFTER MAKING RESECTIONS FOR THE PLANNED SIZE 5 FEMORAL CUT BLOCK, THE ANTERIOR CUT WAS LESS THAN INDICATED ON THE PLAN AND WOULD RESULT IN INSUFFICIENT COVERAGE FOR THE ANTERIOR FLANGE. IT WAS DECIDED TO DOWNSIZE FROM THE 5 TO A SIZE 4. ADD'L CUTS WERE MADE AND ADD'L ANESTHESIA; THE SURGERY WAS COMPLETED SUCCESSFULLY. REFERENCE MFR REPORT NUMBER: 3005180920-2014-00015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109171 MY KNEE FEMUR CUTTING BLOCK #5 RIGHT MEDIAL SINGLE USE SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA USA INC. 17138K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other