BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 1790137 · Received August 3, 2010

    Report

    Report Number
    2249697-2010-00988
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE FROM THE RESEARCH FACILITY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS THE FOLLOWING MFR NUMBERS: 2249697-2010-00985, 2249697-2010-00986, 2249697-2010-00987.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE ARTHROPLASTY WAS REVISED DUE TO DEEP INFECTION AND GROSS LOOSENING OF FEMOROTIBIAL COMPONENTS. THE FEMORAL, TIBIAL AND PATELLAR COMPONENTS WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU 5.7Y (FEM, TIB TRAY) & 4.1Y (TIB INSERT, PATELLA). THE PATIENT PRESENTED WITH A (B)(6) SCORE OF 8 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 10." INFORMATION PROVIDED INDICATED THAT REPORTED DEVICE WAS IMPLANTED IN 2001 AND EXPLANTED IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T01C511

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention