BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ARDIS

    MDR report key: 6577722 · Received May 19, 2017

    Report

    Report Number
    3005751028-2017-00027
    Event Type
    Injury
    Date Received
    May 19, 2017
    Report Date
    May 19, 2017
    Manufacturer
    ZIMMER TMT
    Product Code
    MAX
    PMA / PMN Number
    PK113561
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR. (B)(6) FILED A COMPLAINT REPORTING MIGRATION OF A TM ARDIS IMPLANT. TWO MONTHS AFTER THE ORIGINAL SURGERY, POSTERIOR MIGRATION WAS OBSERVED AND THE IMPLANT WAS REPOSITIONED. THE SURGERY PUSHED THE ORIGINAL TM ARDIS IMPLANT ANTERIORLY BACK INTO POSITION AND A COUPLE WEEKS AFTER, IT WAS REPORTED TO HAVE MIGRATED AGAIN. THE PATIENT ELECTED NOT TO HAVE A SECOND REVISION. SINCE THE IMPLANT WAS NOT RECEIVED AND THE ITEM NUMBER AND LOT NUMBER ARE UNKNOWN, THE DHR COULD NOT BE REVIEWED. THE EXACT REASON FOR MIGRATION IS UNKNOWN; IT WAS NOT CONFIRMED THAT BONE AUTOGRAFT WAS USED. IF MORE INFORMATION IS RECEIVED THAT WILL CONTRIBUTE TO THIS INVESTIGATION, THIS INVESTIGATION MAY BE RE-OPENED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, IT WAS REPORTED BY THE DR. THAT HE HAS A PATIENT WHERE THE TM ARDIS CAGE MIGRATED TWICE TOWARDS THE POSTERIOR. ON MAY 8, 2017 - RECEIVED INFORMATION ABOUT A SURGERY TO REPOSITION THE IMPLANT PLUS X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358775 TM ARDIS TM ARDIS MAX ZIMMER TMT UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention