BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB SM 11

    MDR report key: 4090553 · Received September 15, 2014

    Report

    Report Number
    0002249697-2014-03483
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    September 10, 2007
    Report Date
    August 25, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K032163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES NOTED IN THE REPORT: DCON STD BEADED FEM LFT S, CAT # 66300210, LOT # E7112LUJPJ. DURACON UNIVERSAL B/P NON- BEADED, CAT # 6632-3-605, LOT # OUHA. DURA DURATION ALL POLY PAT SM, CAT # 6642-2-050, LOT # 204021M. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A DURA DURATION A/P TIB SM 11 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570460 DURA DURATION A/P TIB SM 11 IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R