BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C/M INTERCHANGEABLE ULNAR ASSEMBLY

    MDR report key: 2220289 · Received August 16, 2011

    Report

    Report Number
    1822565-2011-01873
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS THE SURGICAL NOTES AND X-RAYS HAVE NOT BEEN PROVIDED, WE ARE UNABLE TO ACCESS THE FIT AND ORIENTATION OF THE IMPLANTS PER THE SURGICAL TECHNIQUE. IT SHOULD BE NOTED THAT THE PATIENT'S ACTIVITY LEVEL HAS BEEN NOTED AS HIGH. THE ZIMMER "COONRAD/MORREY TOTAL ELBOW" BOOKLET INCLUDED WITH THE IMPLANT STATES THAT THE PATIENT MUST NOT LIFT MORE THAN 5 POUNDS WITH THE OPERATED ARM. THE PATIENT'S HIGH ACTIVITY LEVEL MAY HAVE CONTRIBUTED TO THE ULNAS LOOSENING. HOWEVER, WITH THE INFORMATION PROVIDED, AN EXACT CAUSE CANNOT BE DETERMINED. EVALUATION: RETURNED FOR EVALUATION ARE THE HUMERAL AND ULNA BUSHINGS ONLY. AS SUCH THE CONDITION OF THE ULNA COMPONENT IS UNKNOWN. AS RETURNED, THE ULNA BUSHING APPEARS TO BE IN GOOD CONDITION WITH LITTLE WEAR. THE TWO HUMERAL BUSHINGS DO SHOW WEAR. IT IS POSSIBLE THAT THE LOOSE ULNA COMPONENT CAUSED UNANTICIPATED STRESS ON THE HUMERAL BUSHINGS ACCELERATING THEIR WEAR. THE RETURNED PARTS WERE DIMENSIONALLY ANALYZED AND FOUND TO BE CONFORMING WHERE MEASURED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 6 MONTHS AFTER IMPLANTATION DUE TO LOOSENING OF THE ULNA COMPONENT. IT IS ALSO REPORTED THAT ONCE REMOVED, THE BUSHINGS DISPLAYED WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C/M INTERCHANGEABLE ULNAR ASSEMBLY JDC ZIMMER, INC. 61572092

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention COONRAD/MORREY INTERCHANGEABLE HUMERAL| ASSEMBLY, CATALOG #32810502604, LOT# 60943749