BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CEMENTED PS FEMORAL COMPONENT #7 RIGHT

    MDR report key: 1000196 · Received February 19, 2008

    Report

    Report Number
    2249697-2008-00038
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 18, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION, HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT WAS DIAGNOSED WITH AN INFECTION IN 2008, AND AN INCISION WAS MADE TO DRAIN THE WOUND AT THE MEDICAL CENTER. A CULTURE WAS OBTAINED AND NO GROWTH WAS REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON CEMENTED PS FEMORAL COMPONENT #7 RIGHT INSTRUMENT JWH STRYKER ORTHOPAEDICS MAHWAH NA H1117

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention