BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE SHOULDER GLENOSPHERE DISTRACTOR

    MDR report key: 3042519 · Received April 4, 2013

    Report

    Report Number
    1822565-2013-00599
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DISTRACTORS MISFIRED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138449 REVERSE SHOULDER GLENOSPHERE DISTRACTOR HSD ZIMMER, INC. 62269856

    Patients

    Seq Age Sex Outcome Treatment
    1 REVERSE SHOULDER GLENOSPHERE DISTRACTOR:| CATALOG #00430904900, LOT #62269856