BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIOFLEX PS TIB INSERT

    MDR report key: 1790135 · Received August 3, 2010

    Report

    Report Number
    2249697-2010-00990
    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
    MBH
    PMA / PMN Number
    K033972
    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 MFR # 2249697-2010-00989.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE ARTHROPLASTY WAS REVISED DUE TO FEMORAL LOOSENING AND INSTABILITY. THE FEMORAL, TIBIAL INSERT AND PATELLAR COMPONENTS WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 1.5 Y (TIBIAL INSERT), 3.5 Y (FEMORAL/PATELLAR). THE PATIENT PRESENTED WITH A (B)(6) SCORE OF 3 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 6." INFORMATION PROVIDED INDICATED THAT REPORTED DEVICES WERE IMPLANTED IN 2003 AND EXPLANTED IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIOFLEX PS TIB INSERT IMPLANT MBH STRYKER ORTHOPAEDICS MAHWAH NA 17214201

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention