BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DURACON FEMORAL COMPONENT

    MDR report key: 1981785 · Received February 1, 2011

    Report

    Report Number
    2249697-2011-00115
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS KEPT BY THE HOSPITAL AND NOT RETURNED TO THE MANUFACTURER. INFORMATION PROVIDED STATED THAT IT WAS NOT IMPLANT FAILURE. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "REVISION OF A DURACON KNEE WHICH WAS IMPLANTED IN 2003. THE REASON WAS A LOOSE FEMORAL COMP. REPLACED FEMORAL COMP WITH A TRIATHLON TS FEMUR. THE TIBIAL COMP. WAS IN GOOD SHAPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DURACON FEMORAL COMPONENT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention