BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 3/14MM

    MDR report key: 6847606 · Received September 7, 2017

    Report

    Report Number
    3005180920-2017-00492
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 8, 2017
    Report Date
    September 7, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825132
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. SHE HAD A PRIMARY USING NON-MEDACTA PRODUCT. ON (B)(6) 2017 THE PATIENT WAS REVISED AND HAD MEDACTA PRODUCT IMPLANTED AS PART OF AN ANTIBIOTIC SPACER. ON (B)(6) 2017 THE SURGEON REMOVED ALL MEDACTA COMPONENTS AND IMPLANTED PERMANENT PRODUCT. IN AUGUST 2017 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 161840: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 APRIL 2016. EXPIRATION DATE: 2021-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628943 GMK-HINGE FIXED TIBIAL INSERT SIZE 3/14MM FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 161840 07630030825132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention