BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT

    MDR report key: 7013793 · Received November 9, 2017

    Report

    Report Number
    3005180920-2017-00642
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 9, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TIBIAL MOBILIZATION IN CEMENTED TKA 5.5 YEARS AFTER PRIMARY. THE VERY LOW QUALITY IMAGES SHOW THAT COMPONENTS WERE APPARENTLY PLACED CORRECTLY; PERHAPS AN UNEVEN CEMENT MANTLE MAY HAVE AFFECTED LONG TERM PERFORMANCE OF THE TIBIA, BUT THIS CANNOT BE STATED WITH CERTAINTY WITH THE PAUCITY OF INFORMATION AVAILABLE. HOWEVER, THERE IS NO INDICATION THAT A FAULTY COMPONENT ORIGINATED THE PROBLEM. BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 113787: (B)(4) ITEMS MANUFACTURED AND RELEASED ON DECEMBER 19, 2011. EXPIRATION DATE: 10/31/2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO ANTERIOR KNEE PAIN AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT CONFIRMED BY SPEC-CT. THE SURGEON EXPLANTED AND REPLACED THE TIBIA AND INLAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793662 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 113787 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention