BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB SM 11

    MDR report key: 1842819 · Received September 15, 2010

    Report

    Report Number
    9616680-2010-00569
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 26, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K915512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE FROM THE RESEARCH FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY. THE TIBIAL INSERT COMPONENT WAS REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 7.6 Y. THE (B)(6) SCORES WERE NOT RECORDED FOR THIS PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA DURATION A/P TIB SM 11 IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA XNPPA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention