BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR4 - 12

    MDR report key: 3143118 · Received May 29, 2013

    Report

    Report Number
    3005751028-2013-00045
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K012866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED IMPLANT ALSO NOT REVISED - 04-211-35101 TM PATELLA, LOT NUMBER 61177565. 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 PT'S LEGAL COUNSEL THAT THE PT RECEIVED A RIGHT TKA ON (B)(6) 2009. THE PT IS FILING A LEGAL CLAIM FOR REASONS UNK. AT THIS TIME THERE IS NO REVISION SURGERY SCHEDULED OR PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237209 NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR4 - 12 TM MONOBLOCK TIBIA JWH ZIMMER TMT 61011964

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention