BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNITREAX ENDOPROSTHESIS

    MDR report key: 2619256 · Received June 9, 2009

    Report

    Report Number
    2619256
    Event Type
    Other
    Date Received
    June 9, 2009
    Date of Event
    March 20, 2009
    Report Date
    April 24, 2009
    Manufacturer
    HOMEDICA OSTEONICS CORP (A STRYKER CORP)
    Product Code
    JDI
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STRYKER REP OPENED IMPLANT BOX ONTO STERILE FIELD, HANDED THE OPERATING ROOM CIRCULATOR THE OUTER BOX. CIRCULATOR NOTED EXP DATE AND IMMEDIATELY INFORMED THE REP AND SURGEON OF EXP DATE. REP EXPLAINED TO SURGEON THAT THE EXP DATE PERTAINED TO THE BOX AND OUTER WRAPPING. PHYSICIAN CHOSE TO USE THE EXPIRED IMPLANT. HE WAS MADE AWARE THAT THERE WAS ANOTHER IMPLANT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNITREAX ENDOPROSTHESIS HIP IMPLANT JDI HOMEDICA OSTEONICS CORP (A STRYKER CORP) A04C24204058

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR