BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 LEFT

    MDR report key: 6957341 · Received October 18, 2017

    Report

    Report Number
    3005180920-2017-00594
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    September 19, 2017
    Report Date
    October 18, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 170414: 80 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: (B)(6) 2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 52 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    UPON IMPACTION OF THE TIBIAL TRAY, THE PATIENT FRACTURED AT THE TIBIA. THE SURGEON USED BONE GRAFT AND 2 SCREWS TO STABILIZE THE FRACTURE. THERE WAS A ~20 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736767 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 LEFT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 170414 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other