BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW®

    MDR report key: 7049017 · Received November 21, 2017

    Report

    Report Number
    7049017
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 3, 2017
    Manufacturer
    FOURNITURES HOSPITALIERES INDUSTRIE
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE OPENING THE GLENOSPHERE FOR THE PATIENT THE SCRUB NOTICED A WHITE RESIDUE ON THE IMPLANT. NOTIFIED THE SURGEON, AND OPENED 2 OTHER IMPLANTS WITH THE SAME RESULT, UTILIZING 2 DIFFERENT LOT NUMBERS. THE RESIDUE APPEARS TO BE FROM THE PACKAGING. AT THIS POINT, WITH THE THIRD IMPLANT, THE SURGEON CHOSE TO COPIOUSLY RINSE OFF THE IMPLANT WITH SALINE AND IMPLANT IT INTO THE PATIENT. THE TWO IMPLANTS THAT WERE NOT USED WERE GIVEN BACK TO THE REP TO SEND BACK TO THE VENDOR. THE REP STATED THESE WERE STERILIZED IN (B)(4), REPORT WAS MADE TO HIS COMPANY AND HE PULLED HIS STOCK OFF THE SHELF. NOTE: THE OPERATING ROOM NURSE POINTED OUT THE IMPLANTS ARE PACKED IN WHITE STYROFOAM; THE RESIDUE APPEARS LIKE LITTLE SNOWFLAKES, POSSIBLE RELATED TO THE STYROFOAM? MANUFACTURER RESPONSE FOR SHOULDER IMPLANT, GLENOSPHERE (PER SITE REPORTER). THE OPERATING ROOM CALLED THE VENDOR TO TELL THEM OF THIS WHITE RESIDUE. THE VENDOR REPLIED THAT THEY HAVE "NEVER HEARD OF THAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830684 ARROW® PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS FOURNITURES HOSPITALIERES INDUSTRIE 265152 - COCR GLENOSPHERE, Ø42 D00039

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR