BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM MONOBLOCK TIBIA

    MDR report key: 3143135 · Received May 29, 2013

    Report

    Report Number
    3005751028-2013-00052
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 5, 2012
    Report Date
    May 29, 2013
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 CR MONOBLOCK TIBIA ON (B)(6) 2004. ON (B)(6) 2012, THE PATIENT WAS REVISED DUE TO HIS KNEE BEING WEAK, UNSTABLE AND PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234206 TM MONOBLOCK TIBIA TM MONOBLOCK TIBIA JWH ZIMMER TMT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention