BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM REVERSE SHOULDER GLENOSPHERE DISTRACTOR

    MDR report key: 2619371 · Received June 13, 2012

    Report

    Report Number
    1822565-2012-01251
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE INSTRUMENT FROM ITS PACKAGING, THE INSTRUMENT WAS CHECKED BY THE SURGEON AND THE TRIGGER WAS NOTED TO BE STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM REVERSE SHOULDER GLENOSPHERE DISTRACTOR HSD ZIMMER INC 62039450

    Patients

    Seq Age Sex Outcome Treatment
    1