BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM

    MDR report key: 5629913 · Received May 4, 2016

    Report

    Report Number
    3005180920-2016-00203
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    April 5, 2016
    Report Date
    October 12, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 31 MAY 2016 AND INCLUDES: FOLLOW UP 6 MONTH (B)(6): NO DISCOMFORT FOR PATIENT. NEW APPOINTMENT (B)(6): THE DECISION WILL BE TAKEN WHETHER OR NOT FOR A NEW SURGERY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 12 SEPTEMBER 2016 AND INCLUDES: THE SURGEON KEEPS IN TOUCH WITH THIS PATIENT. NO REVISION SURGERY HAS BEEN PLANNED AT THIS MOMENT.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: AFTER 7 MONTHS FROM REVISION TKA, THE SCREW THAT SERVES AS ADDITIONAL FIXATION DEVICE BETWEEN INSERT AND BASEPLATE BROKE OFF AND GOT LOOSE. THE RADIOGRAPH REPRESENTS A POSITION OF THE SCREW THAT IS NOT IMMEDIATELY DANGEROUS BUT WILL PROBABLY CAUSE PAIN AND NEEDS TO BE REMOVED (PERHAPS ARTHROSCOPICALLY) IN ORDER TO AVOID FUTURE POSSIBLE PROBLEMS. THE INSERT IS NOT VERY THICK AND IT'S VERY LIKELY THAT NO FURTHER CONSEQUENCES SHOULD BE EXPECTED FOR THE ABSENCE OF THE SCREW IN CLINICAL USE. FROM THE CLINICAL POINT OF VIEW, NO ROOT CAUSE CAN BE DETERMINED FOR THE SCREW FRACTURE: THE SCREW IS VERY DIFFICULT TO BREAK BY HAND TIGHTENING, AND THE POLYETHYLENE UNDER THE HEAD SHOULD ACT AS AN ELASTIC WASHER. A MECHANICAL CONDITION LEADING TO FRACTURE CAN ONLY BE IMAGINED BUT THERE IS NO EVIDENCE OF HOW IT DEVELOPED. BATCH REVIEW PERFORMED ON (B)(4) 2016. LOT 143009: 25 ITEMS MANUFACTURED AND RELEASED ON 16 JULY 2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT EXPLANTED.

    Description of Event or Problem · 1

    INSERT SCREW BREAKAGE DETECTED 7 MONTHS AFTER PRIMARY SURGERY. NO CLINICAL ISSUES YET. PERFECT FUNCTIONAL OUTCOME. NO ADDITIONAL SURGERY PLANNED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286794 GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 143009

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other