BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 1749201 · Received June 30, 2010

    Report

    Report Number
    2249697-2010-00781
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    June 11, 2009
    Report Date
    June 11, 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

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: SCORPIO PS TIB INSERT, CAT#72-3-0512; LOT 19392901. SCORPIO PS FEMUR WAFFLE POSTS W/LFIT, CAT# 71-4505L; LOT K04H626. SCORPIO U-DOME PATELLA, CAT# 73-3708; LOT R549. SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE, CAT# 6197-9-001; LOT MFL015. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE FEMORAL, TIBIAL AND PATELLAR COMPONENTS WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITY FOR 5.1 Y. THE PATIENT PRESENTED WITH A (B) (6) SCORE OF 4 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 7." INFORMATION PROVIDED INDICATED THAT REPORTED DEVICES WERE IMPLANTED IN 2004 AND EXPLANTED IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T04S508

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention