BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 4 -

    MDR report key: 2922492 · Received January 11, 2013

    Report

    Report Number
    3005751028-2013-00004
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 29, 2011
    Report Date
    January 11, 2013
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K020295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED BY THE PT'S LEGAL COUNSEL THAT THE PT RECEIVED A TKA ON (B)(4) 2009. ON (B)(4) /2011, THE PT WAS REVISED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16488 NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 4 - MONOBLOCK TIBIA JWH ZIMMER TMT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention