BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM

    MDR report key: 7442502 · Received April 19, 2018

    Report

    Report Number
    3005180920-2018-00249
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    April 29, 2015
    Report Date
    April 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825064
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 APRIL 2018. 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, 19 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 3 YEARS AFTER PRIMARY THE SURGEON SWAPPED THE PATIENT LINER FOR A KNEE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286994 GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 143009 07630030825064

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention