BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURACON

    MDR report key: 734292 · Received June 15, 2006

    Report

    Report Number
    734292
    Event Type
    Other
    Date Received
    June 15, 2006
    Date of Event
    April 20, 2006
    Report Date
    June 15, 2006
    Manufacturer
    STRYKER HOWMEDICA OSTEONICS, INC.
    Product Code
    HSA
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    STRYKER REPRESENTATIVE BROUGHT IN IMPLANT TO USE IN SURGERY AFTER TALKING WITH THE PHYSICIAN. IMPLANT WAS OPENED TO THE FIELD DURING TOTAL KNEE REPLACEMENT REVISION. THE NURSE IN THE ROOM NOTICED THAT THE PACKAGE SAID THE IMPLANT WAS EXPIRED. IT WAS NOT IMPLANTED AT THIS TIME. IMPLANT REMOVED FROM SURGICAL FIELD AND PLACED IN AUTOCLAVE FOR 10 MINUTES AND THEN IMPLANTED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON SPACER, FEMORAL, DISTAL HSA STRYKER HOWMEDICA OSTEONICS, INC. * 01053 HSHOE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR