BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM: TIBIA COMPONENT

    MDR report key: 2104087 · Received May 18, 2011

    Report

    Report Number
    3005180920-2011-00029
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 18, 2011
    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: FOR THE THREE LOTS INVOLVED, ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MFG. THE WASHING CYCLES WERE RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLES WERE PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. IN ADDITION: GMK TIBIA COMPONENT REF. (B)(4)/ LOT.102927: 24 PIECES BELONGING TO THIS LOT (TOTAL 36 PCS) HAVE BEEN IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. GMK STD FEMUR COMPONENT REF. (B)(4). LOT.102891: 10 FEMURS BELONGING TO THIS LOT (TOTAL 12 PCS) HAVE BEEN IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. GMK STD FIXED INSERT REF. (B)(4)/ LOT.104101: 9 LINERS BELONGING TO THIS LOT (TOTAL 30 PCS) 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 RECORDS REVIEW AND THE ABSENCE OF INFECTION EVENTS ON THE OTHER PIECES OF THE SAME LOTS, A DEVICE INVOLVEMENT IS HIGH UNLIKELY.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED THE PRIMARY GMK TOTAL KNEE ON (B)(6) 2011. DUE TO A BACTERIAL INFECTION, HE REVISED THE KNEE ON (B)(6) 2011 (FEMORAL COMPONENT AND TIBIAL INSERT). HE USED AN ANTIBIOTIC BONE CEMENT SPACER FOR THE TIBIAL BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMK TOTAL KNEE SYSTEM: TIBIA COMPONENT TOTAL KNEE IMPLANTS: FEMUR-INSERT-TIBIA JWH MEDACTA INTERNATIONAL, SA 102927

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GMK CEMENTED FEMUR COMPONENT: (B)(4)| LOT 102891| GMK FIXED LINER: REF. (B)(4)/ LOT 104101