BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE II CONGRUENT TIBIAL INSERT

    MDR report key: 2113438 · Received May 31, 2011

    Report

    Report Number
    1822565-2011-01282
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE II CONGRUENT TIBIAL INSERT KNEE PROSTHESIS JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NATURAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE| CATALOG# 621200210, LOT# 1482065