BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS CEMENTED TIBAL BASE PLATE SIZE 2

    MDR report key: 3242439 · Received July 17, 2013

    Report

    Report Number
    3006639916-2013-00083
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 17, 2013
    Manufacturer
    MEDACTA USA INC.
    Product Code
    JWH
    PMA / PMN Number
    K081023
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A VISIT TO THE HOSPITAL THE PATIENT COMPLAINED ABOUT PAIN IN HER TIBIA AND IT WAS DISCOVERED THAT THE TIBIA WAS FRACTURED. THE SURGEON WILL DECIDE WHETHER REVISION SURGERY IS REQUIRED AFTER MONITORING HER CONDITION FOR A WHILE. THE SURGEON SUSPECTS THAT THE FRACTURE COULD HAVE OCCURRED NATURALLY EVEN IF IT IS DIFFICULT TO JUDGE IT. REF MFR NUMBER: 3005180920-2013-00083.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332957 EVOLIS CEMENTED TIBAL BASE PLATE SIZE 2 KNEE TIBIAL COMPONENT JWH MEDACTA USA INC. 125621

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention