BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY

    MDR report key: 1003815 · Received February 26, 2008

    Report

    Report Number
    1822565-2008-00066
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Report Date
    December 4, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO POST-OPERATIVE X-RAYS OR ANY OTHER VISUAL MEANS HAS BEEN PROVIDED TO CONFIRM WHETHER THE LOCKING OF THE PIN OCCURRED IN THE FIRST PLACE. THIS TYPE OF FRACTURE OF THE INNER PIN MAY OCCUR DUE TO THE FATIGUE CAUSED BY THE ACTIVITY LEVEL OF THE PT OR DUE TO INSUFFICIENT ENGAGEMENT OF THE PINS DURING SURGERY, LEADING TO STRESS RISERS. THE EXACT CAUSE ANALYSIS CANNOT BE DETERMINED WITH CERTAINTY. AS RETURNED, ALL FOUR OF THE TINES OF THE INNER PIN HAVE FRACTURED OFF. THE BODY OF THE INNER PIN SHOWS DISCOLORATION AND WEAR. SCANNING ELECTRON MICROSCOPY ANALYSIS INDICATES THE FRACTURE OCCURRED BY FATIGUE. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS CONFIRMED THE MATERIAL TO BE TIVANIUM ALLOY. THE OUTER PIN SHOWS SOME MINOR GALLING/STRIATIONS. THE POLY BUSHINGS WERE NOT RETURNED WITH THE COMPLAINT FOR REVIEW. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2005. AN X-RAY REVEALED THAT THE LOCKING CLIP HAS COME APART. A REVISION SURGERY HAS NOT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY ELBOW PROSTHESIS JDC ZIMMER, INC. NA 60222567

    Patients

    Seq Age Sex Outcome Treatment
    1 ASSEMBLY| CATALOG # 32810505301| COONDRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR