BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 2192482 · Received June 30, 2011

    Report

    Report Number
    2249697-2011-00980
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INSERT WAS PLACED INTO TIBIAL BASEPLATE AND A FINAL ROM PERFORMED. SURGEON FELT THAT THE FEMORAL CONDYLES WERE NOT ARTICULATING CORRECTLY WITH THE SULCUS OF THE INSERT. HE COULD CREATE SOME VARUS/VALGUS MOVEMENT AGAINST THE RAISED ISLAND IN THE CENTER OF THE INSERT. HE QUESTIONED WHETHER THE INSERT IS CORRECTLY MACHINED AND WITHIN TOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON CR X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MKE24E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other