BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM MONOBLOCK TIBIA

    MDR report key: 3143129 · Received May 29, 2013

    Report

    Report Number
    3005751028-2013-00041
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 WITHIN AN ARTICLE FROM THE JOURNAL OF ARTHROPLASTY THAT A STUDY REPORTED FAILURES OF A TM MONOBLOCK TIBIA MEDIAL TIBIAL COLLAPSE. THE TIBIAL COMPONENTS DEMONSTRATED A CONSISTENT RADIOGRAPHIC FAILURE MODE CHARACTERIZED BY A CAVITARY MEDIAL DEFECT, MEDIAL SUBSIDENCE OF THE BASEPLATE, WELL FIXED LATERAL FIXATION PEG AND TENSION FAILURE OF THE LATERAL PEG-BASEPLATE JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234204 TM MONOBLOCK TIBIA TM MONOBLOCK TIBIA JWH ZIMMER TMT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention