BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TM REVERSE SHOULDER HUMERAL STEM

    MDR report key: 1923210 · Received November 9, 2010

    Report

    Report Number
    1822565-2010-01087
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 29, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 REAMED FOR A 12 MM STEM BUT WHEN INSERTING THE TRIAL, FOUND THAT IT FIT LOOSELY. HE THEN HAD TO RE-REAM AND INSERT A 14 MM STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TM REVERSE SHOULDER HUMERAL STEM SHOULDER PROSTHESIS HSD ZIMMER INC. 61444376

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR