BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL TRAY SIZE T3I4 RIGHT

    MDR report key: 4173762 · Received September 25, 2014

    Report

    Report Number
    3006639916-2014-00127
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GMK SPHERE CEMENTED FIXED TIBIAL TRAY SIZE T3I4 RIGHT: CODE 02.12.T3I4R / LOT 113551 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    SURGEON REVISED THE TIBIALR TRAY DUE TO TILTED AND LOOSENING DUE TO ANTEROMEDIAL PLATEAU FRACTURE. HE REPLACED IT WITH A TRAY OF THE SAME SIZE AND A LONG STEM OFFSET CONNECTOR. MFR REF# 3005180920-2014-00127.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596614 GMK SPHERE TIBIAL TRAY SIZE T3I4 RIGHT KNEE FIXED CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 113551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention