BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION GLENOID COMPO

    MDR report key: 774804 · Received October 27, 2006

    Report

    Report Number
    1822565-2006-00254
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    August 28, 2006
    Report Date
    September 25, 2006
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: WEAR IN VIVO MIGHT HAVE OCCURRED DUE TO ABRASIVE ACTION OF BONE CEMENT PARTICLES OR PATIENT ACTIVITY LEVEL MAY HAVE RESULTED IN AGGRESSIVE WEAR PATTERN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. DEVICE EXHIBITS EXTENSIVE WEAR TO ARTICULATING SURFACE, PREDOMINANTLY ON ONE SIDE. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. DEVICE MEETS DIMENSIONAL SPECIFICATION WHERE MEASURED. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF MATERIAL SHOWED A CARBON (C) PEAK IN SPECTRUM TYPICAL OF UHMWPE. THIRD BODY PARTICLES OBSERVED ON SURFACE SHOWED CA, K, CI, S, NA, MG, C, AND O ELEMENTAL PEAKS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2004. PATIENT BEGAN EXPERIENCING PAIN ONE YEAR POST-OP. X-RAY REVEALED 1-5MM OF DISTAL MIGRATION AT 22 MONTHS. ON AUGUST 28, 2006, SURFACE WAS REVISED DUE TO POLYTHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION GLENOID COMPO SHOULDER PROSTHESIS KWT ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R