BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3005180920-2018-00764

    MDR report key: 7947334 · Received October 9, 2018

    Report

    Report Number
    3005180920-2018-00764
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 9, 2018
    Report Date
    November 8, 2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON OCT 09, 2018 BY SALES REP: LEFT SIDE OPERATED, SIZE 3. ADDITIONAL COMPONENT INVOLVED: GMK-REVISION 02.07.10.3633 REVISION TRIAL FEMORAL BOX # 3L. NOTE: INSTRUMENTS LOT NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION MADE BY THE R&D PROJECT MANAGER ON 09 OCT 2018: FROM THE DESCRIPTION OF THE EVENT AND CONSIDERING THE ABSENCE OF IMAGES OF INVOLVED INSTRUMENTS, IT IS NOT CLEAR THE REASON OF THE COMPLAINT. HOWEVER WE CAN HYPOTHESIZE THAT THE ISSUE OCCURRED DUE TO AN INCORRECT ASSEMBLY BETWEEN THE REVISION TRIAL FEMORAL COMPONENT AND THE TRIAL BOX. IN THIS SITUATION COULD BE THAT THE TRIAL COMPONENTS DOES NOT CORRECTLY FIT WITH THE BONE PREPARATION WITH THE RISK OF LITTLE INTERFERENCE DURING INSERTION & REMOVAL. THE CONNECTION OF THE DISTAL AUGMENTS IS GUARANTEED THROUGH SPRING CONNECTION. IN CASE OF DAMAGE OF THE ELASTIC PART, THE CONNECTION COULD NOT WORK PROPERLY WITH THE MISS OF RETENTIVE FUNCTIONALITY.

    Description of Event or Problem · 1

    DURING THE REVISION SURGERY, PERFORMED ON (B)(6) 2018, THE FEMORAL DISTAL AUGMENTS WOULD NOT ENGAGE, PROBABLY BECAUSE THE TRIAL WAS DAMAGED. WHEN IT WAS CLEANED, WITH THE USE OF A FLAT HEAD SCREWDRIVER IT WAS POSSIBLE TO FIX IT. CCK HOUSING WAS SO TIGHT AND WITH ALL THE BLOOD, GREASINESS OF THE PATIENT, IT WAS NOT POSSIBLE TO LOCK IT IN THE FEMORAL TRIAL. THE SURGEON USED BONE WAX TO HOLD THE INSTRUMENT IN PLACE. ADDITIONALLY, THE HOUSING BLOCK WOULD NOT SCREW INTO THE FEMORAL TRIAL. WHEN THE SURGEON TRIED TO REMOVE THE HOUSING BLOCK, IT WAS DIFFICULT TO REMOVE FROM THE BONE. THE SURGEON USED A BONE TAMP TO PULL THE CCK HOUSING BLOCK OFF. THE SURGEON ALSO COMMENTED THAT THE TIBIAL AUGMENTS BEING TWO SANDWICHED PIECES TO MAKE A 10MM AUGMENT CAUSES ISSUES. THE SURGEON DROPPED THE AUGMENT AND HAD TO RE-STERILIZE IT. THE WHOLE CASE WAS DELAYED APPROXIMATELY 3 HOURS.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other