BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3940565 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02746
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TRIATHLON PS FEMORAL COMPONENT SIZE 4. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. PT DID NOT RELEASE PRODUCT.

    Description of Event or Problem · 1

    SURGEON REMOVED LOOSE TRIATHLON FEMORAL AND TIBIAL COMPONENTS AND REPLACED THEM WITH TRIATHLON TS COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419742 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention