BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE II POROUS STEMMED TIBIAL PLATE

    MDR report key: 3213773 · Received July 3, 2013

    Report

    Report Number
    1822565-2013-01058
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 3, 2013
    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 PATIENT WAS IMPLANTED WITH A NATURAL KNEE TIBIAL BASEPLATE. OSTEOLYTIC LESIONS WERE SHOWN ON X-RAY IN THE TIBIAL HEAD. PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303674 NATURAL KNEE II POROUS STEMMED TIBIAL PLATE JWH ZIMMER, INC. 1540690

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention NATURAL KNEE II CONGRUENT TIBIAL INSERT.| CATALOG #620008909, LOT #1536973