BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMICAP SHOULDER REAMER / GUIDE PIN

    MDR report key: 1869370 · Received October 4, 2010

    Report

    Report Number
    3004154314-2010-00001
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    LXH
    PMA / PMN Number
    K023096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ISSUES NOTED UPON INSPECTION OF THE INSTRUMENT KIT. THE 7.5MM REAMER USED IN THE CASE APPEARED TO BE FUNCTIONAL WITH NO NOTICEABLE DAMAGE TO THE BLADE END. A GUIDE PIN WAS CONTAINED IN THE KIT. THIS WAS THE GUIDE PIN THAT WAS USED TO FINISH THE CASE AND DID DEMONSTRATE SOME TYPICAL WEAR MARKS. THE GUIDE PIN THAT DISENGAGED FROM THE PATIENT AND FELL TO THE FLOOR WAS DISCARDED AT THE SITE. THE GUIDE PIN INSPECTED INSERTED FREELY THROUGH THE INNER DIAMETER OF THE REAMER WITHOUT RESISTANCE. ALL OTHER INSTRUMENTATION WAS REVIEWED AS WELL AND NO ISSUES WERE NOTED. INSTRUMENT KIT 8000-3000 S/N (B)(4) WAS DETERMINED TO BE IN GOOD WORKING ORDER.

    Description of Event or Problem · 1

    ON (B)(6), 2010, DURING THE REAMING STEP OF A SHOULDER HEMI-ARTHROPLASTY PROCEDURE USING AN ARTHOSURFACE HEMICAP SHOULDER IMPLANT, THE REAMER MOVED OFF THE HUMERAL HEAD INTO SOFT TISSUE. BLEEDING OCCURRED AT THE SITE OF THE SOFT TISSUE CONTACT BUT WAS CONTROLLED BY THE SURGEON USING SUTURE PLACEMENT. IT IS BELIEVED THAT, WHILE REAMING, THE GUIDE WIRE LOOSENED IN THE BONE AND NO LONGER PROVIDED A CENTERING AXIS. IT IS NOT KNOWN WHAT CAUSED THE GUIDE PIN TO LOOSEN. THE IMPLANTATION OF THE ARTHROSURFACE HEMICAP WAS COMPLETED. THE PATIENT'S VASCULAR FLOW WAS EVALUATED AND THE PATIENT WAS LATER TAKEN TO AN AREA HOSPITAL AND ADMITTED TO THE CARDIAC ICU. LATER THAT WEEK, IT WAS LEARNED THE PATIENT WAS NO LONGER REGISTERED AT THE HOSPITAL AND WAS BELIEVED TO HAVE BEEN DISCHARGED. IT WAS LEARNED ON (B)(6), THAT THE PATIENT HAD PASSED AWAY. IT WAS VERBALLY COMMUNICATED THAT AN UNRELATED ABDOMINAL EVENT WAS THE CAUSE OF DEATH, BUT THE DETAILS HAVE NOT BEEN PROVIDED. THERE IS NO INFORMATION TO CONCLUDE ANY INVOLVEMENT OF THE ARTHROSURFACE DEVICE WITH THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMICAP SHOULDER REAMER / GUIDE PIN REAMER, GUIDE PIN LXH ARTHROSURFACE, INC. 8359-3075 75LE0926

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H