BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYL

    MDR report key: 546717 · Received September 24, 2004

    Report

    Report Number
    1822565-2004-00095
    Event Type
    Injury
    Date Received
    September 24, 2004
    Date of Event
    February 10, 2004
    Report Date
    August 24, 2004
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED IN 1999 AND POST-OP THE PT WENT TO THE EMERGENCY ROOM WITH A PAINFUL INFECTED KNEE JOINT. SURGEON REMOVED THE BROKEN POST FROM THE ARTICULAR SURFACE AND TREATED THE INFECTION. IN 2004 THE ARTICULAR SURFACE WAS REMOVED AND REPLACED WITH A 00-5994-030-20 SURFACE. IT WAS REPORTED THAT THE COMPONENTS WERE PROPERLY MATCHED AND APPEARED PROPERLY SIZED AND POSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYL KNEE PROSTHESIS JWH ZIMMER, INC. NA 54186100

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R