BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXP TIBIAL INSERTS AND PATELLAR COMPONENTS

    MDR report key: 3922262 · Received July 9, 2014

    Report

    Report Number
    2530191-2014-00005
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    December 17, 2013
    Report Date
    July 9, 2014
    Manufacturer
    STELKAST, INC
    Product Code
    JWH
    PMA / PMN Number
    K122883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE POLY INSERT WAS PLACED ON THE TIBIAL TRY DURING SURGERY BUT WOULD NOT SEAT PROPERLY. THE SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT ANOTHER INSERT OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400667 EXP TIBIAL INSERTS AND PATELLAR COMPONENTS CR HF TIBIAL TRAY INSERT, EXP JWH STELKAST, INC SC3453-5-10 28622-112812

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR