BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL GLENOSPHERE

    MDR report key: 2943218 · Received January 21, 2013

    Report

    Report Number
    1822565-2013-00128
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON ASKED FOR A 40MM GLENOSPHERE. THE CIRCULATOR OPENED A 40MM GLENOSPHERE BASED ON THE DESCRIPTION ON THE BOX. WHEN THE BOX WAS OPENED THE IMPLANT WAS ETCHED AS A 36MM. IT WAS COMPARED TO A DIFFERENT 36MM GLENOSPHERE AND IT WAS CLEARLY LARGER. THE SURGEON IMPLANTED THE LARGER GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29112 ZIMMER TRABECULAR METAL GLENOSPHERE HSD ZIMMER, INC. 62171671

    Patients

    Seq Age Sex Outcome Treatment
    1