BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION SC LINER # 5 / 17 MM

    MDR report key: 3001160 · Received March 7, 2013

    Report

    Report Number
    3005180920-2013-00007
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: (B)(4) REVISION SC LINER SIZE 5 / 17 MM: CODE 02.07.0517SC / LOT 110077 (25 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDING WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE 4 ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE EVENT OCCURED IS HIGHLY UNLIKELY AND THE CHANGE OF THE THICKNESS IS PROBABLY DUE TO A WRONG EVALUATION OF THE KNEE STABILITY DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    PATIENT HAD PAIN. THE INSERT WAS REPLACED WITH A THICKER ONE ABOUT 8 MONTHS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98051 GMK REVISION SC LINER # 5 / 17 MM KNEE TIBIAL SEMI CONSTRAINED COMPONENT LZO MEDACTA INTERNATIONAL, SA 110077

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention