BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED PS LINER SIZE 4 / 14MM

    MDR report key: 2758306 · Received August 30, 2012

    Report

    Report Number
    3005180920-2012-00047
    Event Type
    Injury
    Date Received
    August 30, 2012
    Date of Event
    August 3, 2012
    Report Date
    August 30, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY PS INSERT SIE 4 HEIGHT 14 MM: CODE (B)(4)/ LOT 111387 (49 LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDING WITH THE SPECS VALID AT THE TIME OF MFG. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECS VALID AT THE TIME OF PRODUCTION. FOUR ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE INFECTION OCCURRED IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

    REVISION SURGERY OF THE GMK PRIMARY TIBIAL INSERT ABOUT 4 MONTHS POST OP DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMK FIXED PS LINER SIZE 4 / 14MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL, SA 111387

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention