BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED TIBIAL TRAY SIZE 6 RIGHT

    MDR report key: 4001632 · Received July 24, 2014

    Report

    Report Number
    3005180920-2014-00090
    Event Type
    Injury
    Date Received
    July 24, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY FIXED CEMENTED TIBIAL TRAY SIZE 6 RIGHT: CODE 02.07.1206R/LOT 122307 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. TOTAL OF (B)(4) ITEMS BELONGING TO THIS LOT HAVE ALREADY BEEN SOLD AND NO SIMILAR INCIDENT HAVE BEEN REPORTED. GMK PRIMARY FIXED UC TIBIAL INSERT SIZE 6, 10 MM: CODE 02.07.0610FUC / LOT 104485 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. TOTAL OF (B)(4) ITEMS BELONGING TO THIS LOT HAVE ALREADY BEEN SOLD AND NO SIMILAR INCIDENT HAVE BEEN REPORTED. GMK PRIMARY CEMENTED STANDARD FEMUR SIZE 6 RIGHT: CODE 02.07.2006R / LOT 103129 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. TOTAL OF (B)(4) ITEMS BELONGING TO THIS LOT HAVE ALREADY BEEN SOLD AND NO SIMILAR INCIDENT HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435389 GMK FIXED TIBIAL TRAY SIZE 6 RIGHT FIXED CEMENTED TIBIAL TRAY LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1