BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COONRAD/MORREY ULNAR ASSEMBLY

    MDR report key: 1940482 · Received December 21, 2010

    Report

    Report Number
    1822565-2010-01412
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    May 28, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE PT'S WEIGHT AND ACTIVITY LEVEL MAY HAVE CONTRIBUTED TO THIS SITUATION. IT IS POSSIBLE THAT EXCESSIVE FORCE OR TORQUE WAS PLACED ON THE IMPLANT. THE SCANNING ELECTRON MICROSCOPE ANALYSIS PERFORMED ON THE FRACTURE SURFACES SHOWED THAT THE FRACTURE OCCURRED BY FATIGUE. THE EXACT CAUSE ANALYSIS CANNOT BE DETERMINED WITH CERTAINTY. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS / ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WAS PERFORMED. NO MFG ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR A BROKEN IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COONRAD/MORREY ULNAR ASSEMBLY ELBOW PROSTHESIS JDB ZIMMER, INC. 060719210

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR