BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 1970240 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00014
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    June 14, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK TIBIAL INSERT FIXED POSTERO STABILIZED - (B)(4)/LOT. 080172. DOCUMENT REVIEW WAS CARRIED OUT ON THE LOT 080172 (15 PIECES PRODUCED): ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. ABOUT 6 INSERTS BELONGING TO THIS LOT HAVE BEEN IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE REVISION SURGERY IS ASSOCIATED TO AN INFECTION EVENT. ON THE BASIS OF THE BATCH RECORD REVIEW AND THE ABSENCE OF INFECTION EVENTS ON THE OTHER PIECES OF THE SAME LOT, A DEVICE INVOLVEMENT IS HIGH UNLIKELY.

    Description of Event or Problem · 1

    THERE WAS AN EARLY STAGE INFECTION AFTER THE FIRST SURGERY AND THE SURGEON CHANGED THE INSERT IN A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL PS FIXED INSERT JWH MEDACTA INTERNATIONAL SA NA 080172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention