BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 2170043 · Received July 13, 2011

    Report

    Report Number
    2249697-2011-01050
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: SCORPIO PS BASIC FEMUR CAT # 71-3009L, LOT # UNK. UNKNOWN #9, 10MM PS SCORPIO INSERT CAT # UNK, LOT # UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DUE TO INFECTION, THE IMPLANTS LISTED ABOVE WERE REMOVED AND A TEMP SPACER WAS PUT IN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T04E1248

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention