BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYKNEE PPS STD FEMDISCUTBLOCK-MRI-GMK-RM- SIZE 3

    MDR report key: 18037495 · Received October 31, 2023

    Report

    Report Number
    3005180920-2023-00855
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 31, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030897627
    PMA / PMN Number
    K170106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY INVESTIGATION: THE PLANNING WAS INITIALLY EFFICIENCY BASED AND THEN WAS MODIFIED TO METALLIC BASED AS PER MEDACTA USA REQUEST. HOWEVER, THE SURGEON AND HIS SALES AGENT WERE NOT INFORMED OF THIS MODIFICATION SO THE SURGERY WAS PERFORMED USING EFFICIENCY SET. MYSOLUTION ANALYSIS: OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 0

    MYKNEE SURGERY WAS INTENDED TO BE PERFORMED USING METALLIC INSTRUMENT SET INSTEAD OF EFFICIENCY INSTRUMENT SET (NOTE: THE PLANNING WERE INITIALLY CREATED WITH EFFICIENCY SET BUT THEN CHANGED TO METALLIC SET). HOWEVER, THIS INFORMATION DID NOT REACH THE SURGEON CORRECTLY, WHO PERFORMED THE SURGERY USING THE EFFICIENCY SET. THE DISTAL FEMORAL BONE WAS CUT MORE THAN PLANNED, AND A THICKER LINER WAS USED TO COMPENSATE FOR THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942264 MYKNEE PPS STD FEMDISCUTBLOCK-MRI-GMK-RM- SIZE 3 PATIENT SPECIFIC SURGICAL GUIDE JWH MEDACTA INTERNATIONAL SA 167801K 07630030897627

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other