BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS FEM COMPONENT, CEMENTED

    MDR report key: 1982238 · Received January 24, 2011

    Report

    Report Number
    2249697-2011-00084
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K042993
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME PATIENT/EVENT AS MFR # 9610726-2011-00015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT WAS BROUGHT TO OPERATING ROOM TO REVISE A LOOSE TOTAL KNEE. FEMUR AND TIBIA WERE FOUND TO BE LOOSE AND WERE REVISED WITH TRIATHLON PRIMARY IMPLANTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS FEM COMPONENT, CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA XFYW

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention