BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYO CONSERVATIVE FEMORAL STEM

    MDR report key: 2162033 · Received July 12, 2011

    Report

    Report Number
    1822565-2011-01628
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D 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 THE PT WAS REVISED DUE TO PAIN AND ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYO CONSERVATIVE FEMORAL STEM LPH ZIMMER, INC. 60999260

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention