BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM DISTAL FEMORAL AUGMENT, SIZE: F

    MDR report key: 2801708 · Received October 12, 2012

    Report

    Report Number
    3005751028-2012-00144
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    July 27, 2009
    Report Date
    October 12, 2012
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K024161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ZIMMER KNEE REGISTRY THAT THE PT HAD ALL KNEE COMPONENTS REVISED DUE TO AN INFECTION. IN (B)(6) 2009, THE PT WAS REVISED DUE TO A CHRONICALLY INFECTED RIGHT KNEE. THE IMPLANTS USED WERE NON-ZIMMER DEVICES. ON (B)(6) 2009 THE PT WAS AGAIN REVISED BECAUSE OF INFECTION, USING ZIMMER IMPLANTS WHICH INCLUDED TRABECULAR AUGMENTS FOR THE FEMORAL AND TIBIAL COMPONENTS. THE PT DID WELL WITH THESE IMPLANTS UNTIL (B)(6) 2009, WHEN HE WAS AGAIN REVISED DUE TO INFECTION. THE SURGEON HAS INDICATED THAT THE IMPLANTS WERE NOT THE CAUSE OF THE PT'S INFECTION. THE PT HAS A HISTORY OF RECURRENT INFECTION AND A PREVIOUS HISTORY OF DRUG USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM DISTAL FEMORAL AUGMENT, SIZE: F TM FEMORAL AUGMENT JWH ZIMMER TMT 6118850

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention