BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOS INCLINATION SET

    MDR report key: 1714106 · Received May 21, 2010

    Report

    Report Number
    1714106
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 21, 2010
    Manufacturer
    SMITH & NEPHEW
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS DIAGNOSED WITH OSTEOARTHRITIS OF THE LEFT SHOULDER. A LEFT TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED USING A SMITH AND NEPHEW PROMOS SHOULDER SYSTEM. AFTER HAVING PROBLEMS WITH THE SHOULDER, THE PATIENT CAME BACK ABOUT A YEAR LATER AND HAD THE HARDWARE REMOVED. UPON INVESTIGATION IT WAS FOUND THAT THIS PARTICULAR SCREW SET WAS RECALLED IN JANUARY 2010 (SEVERAL MONTHS BEFORE PATIENT HAD DEVICE REMOVED).====================== HEALTH PROFESSIONAL'S IMPRESSION======================IT WAS FOUND THAT THIS WAS A RECALLED DEVICED BASED ON A 1/14/10 LETTER FROM STERICYCLE, INC. THE PHYSICIAN FELT IT HAD BEEN BROKEN QUITE A WHILE AS HE FOUND THAT THE GLENOID HAD BOTH EVIDENCE OF SIGNIFICANT WEAR AT THE INFERIOR MARGIN AND ALSO A BIG GOUGE IN THE MIDDLE OF THE GLENOID AND EVIDENCE OF SUBTLE LOOSENING OF THE PROSTHESIS.====================== MANUFACTURER RESPONSE FOR INCLINATION SET, PROMOS======================RECALLED 1/14/2010

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOS INCLINATION SET SCREW HSD SMITH & NEPHEW 75006723 A0702052

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR