BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2170233 · Received July 5, 2011

    Report

    Report Number
    1644408-2011-00374
    Event Type
    Other
    Date Received
    July 5, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE REVISION SURGERY WAS IDENTIFIED AS INFECTION. THE ORIGINAL SURGERY OCCURRED 1.4 YEARS PRIOR TO THE REVISION. IT IS UNKNOWN IF THE PATIENT WAS INVOLVED IN ANY OTHER ACTIVITIES THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR HAD ANY PRE-EXISTING CONDITIONS. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORD FOR THE DEVICE WAS EXAMINED. THE REPORTED DEVICE USED IN THE ORIGINAL SURGERY RECEIVED AN ADEQUATE 25-40 KGY GAMMA RAY IRRADIATION STERILIZATION DOSE AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF SURGERY. A REVIEW OF THE ENTIRE PRODUCT COMPLAINT REPORT HISTORY WAS COMPLETED. THERE WAS ONE OTHER COMPLAINT FOR INFECTION FOR THIS PART NUMBER. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORD, PRODUCT COMPLAINT REPORT HISTORY AND STERILIZATION RECORD SHOW THAT THE DEVICE MET STERILIZATION, DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO FINDINGS THAT INDICATE THE DEVICE WAS THE SOURCE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON PERFORMED AN I&D POLY EXCHANGE DUE TO THE PATIENT DEVELOPING AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE POSTERIOR STABILIZED INSERT 500 SERIES JWH ENCORE MEDICAL, L.P. 471122

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention