BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG X3 PS TIBIAL INSERT #5 10MM

    MDR report key: 2831044 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02131
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K071991
    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. DEVICES WERE RETAINED AT DREXEL IMPLANT RESEARCH CENTER. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTIONS AT REPORTERS INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 81-4407R, LOT # TD5MHD DESCRIPTION: SCORPIO NRG PS FEMORAL #7 RIGHT. CAT # 7115-0005 LOT # JD1MRD DESCRIPTION: SERIES 7000 STANDARD TIBIA. CAT # 73-3508, LOT # 12CKLC DESCRIPTION: SCORPIO U-DOME PATELLA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROXIMATELY 4.3 Y. THE TIBIAL INSERT, TIBIAL TRAY, FEMORAL AND PATELLAR COMPONENTS WERE REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 1 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO NRG X3 PS TIBIAL INSERT #5 10MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA M1XMPD

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention