BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 3/23MM

    MDR report key: 9334343 · Received November 18, 2019

    Report

    Report Number
    3005180920-2019-00979
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 24, 2019
    Report Date
    November 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825163
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 4 NOVEMBER 2019. LOT 181584: 44 ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2018. EXPIRATION DATE: 2023-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY PERFORMED 4 MONTHS AFTER THE FIRST REVISION SURGERY DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT SUCCESSFULLY. THE FIRST REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION (INSERT REVISED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132752 GMK-HINGE FIXED TIBIAL INSERT SIZE 3/23MM KNEE TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 181584 07630030825163

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention