BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON INSERT PS#2 9MM

    MDR report key: 4221386 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04108
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT NO FURTHER INFORMATION IS AVAILABLE AS PER SURGEON AND HOSPITAL POLICY. THE EVENT CANNOT BE CONFIRMED BASED UPON THE LIMITED INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD RIGHT KNEE REVISION DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701572 X3 TRIATHLON INSERT PS#2 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R