BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS NEXGEN TM PATELLA, 32MM DIA.

    MDR report key: 1972240 · Received January 21, 2011

    Report

    Report Number
    3005751028-2011-00002
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    July 1, 2009
    Report Date
    January 21, 2011
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K011904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO A FRACTURED PRIMARY PATELLA. PRECEDING OR CONTRIBUTING EVENTS: PATIENT HISTORY: SMOKER, ALCOHOL ABUSE, OSTEOARTHRITIS, SEVERAL FALLS DUE TO DIZZYNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POROUS NEXGEN TM PATELLA, 32MM DIA. NONE JWH ZIMMER TMT 61058833

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention