BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS FEM COMPONENT, CEMENTED

    MDR report key: 2161202 · Received July 8, 2011

    Report

    Report Number
    2249697-2011-01025
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K042993
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME PT/EVENT AS MFR# 2249697-2011-01026. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "LOOSE COMPONENTS WITH SYNOVITIS. MID VASTUS INCISION." ADDITIONAL INFO: "LOOSE FEMORAL AND TIBIAL COMPONENTS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention