BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 4

    MDR report key: 2826305 · Received October 26, 2012

    Report

    Report Number
    3005751028-2012-00151
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    November 29, 2011
    Report Date
    October 26, 2012
    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

    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

    IT WAS REPORTED BY THE PATIENT'S LEGAL COUNSEL THAT THE PATIENT RECEIVED A TKA ON (B)96) 2009. ON (B)(6) 2011, THE PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 4 TM MONOBLOCK TIBIA JWH ZIMMER TMT 61217057

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention