BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6

    MDR report key: 7338227 · Received March 14, 2018

    Report

    Report Number
    3005180920-2018-00140
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 12, 2018
    Report Date
    March 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K170106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER ITEM INVOLVED IN THE CASE IS MYKNEE MIS TIBIAL PIN POSITIONER - MRI - GMK - RIGHT MEDIAL - SIZE 5 REFERENCE 8.2245 (K170106). BATCH REVIEW PERFORMED ON 14 MARCH 2018. (B)(4). ON 19 FEBRUARY 2018 THE PATIENT MATCH DEPARTMENT PERFORMED THE INVESTIGATION ON THE CASE: NO DEVIATIONS OR ANOMALY WERE FOUND.

    Description of Event or Problem · 1

    THE PPS BLOCKS FOR THE CASE FIT WELL, HOWEVER IN SURGERY ADDITIONAL RESECTIONS WERE NEEDED FOR THE FEMUR AND THE TIBIA IN ORDER TO GET FULL EXTENSION. THIS TECHNIQUE TOOK 50-55 MINUTES FOR THE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179911 MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6 FEMUR DISTAL PIN POSITIONER JWH MEDACTA INTERNATIONAL SA 62715K

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other