BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CRUCIATE RETAINING FEMORAL COMPONENT

    MDR report key: 1924425 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01293
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    March 25, 2008
    Report Date
    November 8, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER 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 LOOSENING OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CRUCIATE RETAINING FEMORAL COMPONENT KNEE PROSTHESIS HRY ZIMMER, INC. 60470296

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention