BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 2182442 · Received July 19, 2011

    Report

    Report Number
    2249697-2011-01084
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 29, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: UNKNOWN SCORPIO FLEX CR TIBIAL INSERT CAT# UNK, LOT# UNK, UNKNOWN FEMUR; CAT# UNK, LOT# UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "(B)(6) MALE INJURED IN MOTOR VEHICLE ACCIDENT (B)(6)-2004 RESULTING IN OPEN REDUCTION AND INTERNAL FIXATION. APPROXIMATELY 1 YEAR LATER THE HARDWARE WAS REMOVED FOR A MONTH PRIOR TO PROCEEDING WITH LEFT KNEE ARTHROPLASTY (B)(6) 2005. THE PATIENT INDICATED THAT THE PAIN WAS SHARP CHRONIC THROBBING PAIN ALL DAY LONG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T05H1575

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention