BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER STEM

    MDR report key: 2230780 · Received August 23, 2011

    Report

    Report Number
    1822565-2011-01920
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR 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 THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE. AT THE REVISION, A PORTION OF THE POROUS SURFACE OF THE STEM WAS FOUND TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER STEM MEH ZIMMER, INC. 07887356

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention