BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR4 - 12

    MDR report key: 3203703 · Received June 25, 2013

    Report

    Report Number
    3005751028-2013-00062
    Event Type
    Injury
    Date Received
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K012866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMPLANT'S MFG RECORD INDICATES THAT IT WAS MFG TO SPECIFICATION. BASED ON THE INFO AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. SHOULD ADDITIONAL INFO 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)(6) 2004. THE PT WAS REVISED ON (B)(6) 2006, DUE TO PAIN AND MEDICAL SUBSIDENCE OF THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286810 NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR4 - 12 NONE JWH ZIMMER TMT 56461507

    Patients

    Seq Age Sex Outcome Treatment
    1