BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COONRAD/MORREY HUMERAL ASSEMBLY

    MDR report key: 1062603 · Received June 18, 2008

    Report

    Report Number
    1822565-2008-00334
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. EVAL SUMMARY: NO POST OPERATIVE X-RAY OR ANY OTHER VISUAL MEANS HAS BEEN PROVIDED TO CONFIRM WHETHER 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 DEVICE HISTORY IS UNAVAILABLE (NO LOT NUMBER). THE EXACT CAUSE ANALYSIS CAN NOT BE DETERMINED WITH CERTAINTY. EVAL: THE RETURNED DEVICE MEETS SPECIFICATION WHERE MEASURABLE IN THIS CURRENT CONDITION. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2008. REVISION SURGERY OCCURRED THE FOLLOWING MONTH, DUE TO BREAKAGE OF THE HINGE PIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R