BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER REVERSE CUSTOM BASE PLATE

    MDR report key: 2133653 · Received June 16, 2011

    Report

    Report Number
    1822565-2011-01436
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER EXPERIENCING A FALL, THE PT HAD TO BE REVISED. WHEN REMOVING THE SHOULDER BASEPLATE, THE SURGEON EXPRESSED CONCERN ABOUT THE LACK OF BONY INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER REVERSE CUSTOM BASE PLATE CUSTOM SHOULDER PROSTHESIS HSD ZIMMER, INC. 95002560

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention