BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM 400

    MDR report key: 3946318 · Received July 9, 2014

    Report

    Report Number
    3005751028-2014-00046
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO HAD A TM 400 IMPLANTED, WAS UNDERGOING REVISION SURGERY DUE TO SUSPECTED PSEUDARTHROSIS; HOWEVER, THE REVISION WAS NOT COMPLETED AS THE SURGEON COULD NOT MOBILIZE THE VESSELS IN ORDER TO REMOVE THE IMPLANT. NO FURTHER INFORMATION WAS RECEIVED (I.E., DATE OF OCCURRENCE, PART LOT NUMBER, ETC.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399072 TM 400 TM 400 JWH ZIMMER TRABECULAR METAL TECHNOLOGY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention