BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR6 - 10

    MDR report key: 3143095 · Received May 29, 2013

    Report

    Report Number
    3005751028-2013-00046
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 19, 2010
    Report Date
    May 29, 2013
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K012866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMPLANT'S MANUFACTURING RECORD INDICATES THAT IT WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BE OBTAINED TO FURTHER THIS INVESTIGATION. THIS REPORT SHALL BE UPDATED.

    Description of Event or Problem · 1

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE NEXGEN FEMORAL COMPONENT. IT WAS REPORTED BY THE PT'S COUNSEL THAT THE PT RECEIVED AN IMPLANT ON (B)(6) 2005 AND WAS REVISED ON (B)(6) 2010, DUE TO PAIN AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235910 NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR6 - 10 TM MONOBOLCK TIBIA JWH ZIMMER TMT 603287674

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention