BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS FEM COMPONENT, CEMENTED

    MDR report key: 1000195 · Received February 19, 2008

    Report

    Report Number
    2249697-2008-00039
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 24, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K042993
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT PRESENTED WITH FLUID IN THE KNEE SEVERAL MONTHS AFTER TRIATHLON TKR. KNEE WAS DRAINED. NO SIGN OF INFECTION."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention