BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM COLLAR 35 MM O.D.

    MDR report key: 7788577 · Received August 16, 2018

    Report

    Report Number
    3005751028-2018-00040
    Event Type
    Injury
    Date Received
    August 16, 2018
    Report Date
    July 13, 2018
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY ON (B)(6) 2015 WITH A SEGMENTAL SYSTEM AND SUBSEQUENTLY EXPERIENCED POSTOPERATIVE DEEP VEIN THROMBOSIS. CONTRIBUTING FACTORS TO THE PATIENT'S POST-OPERATIVE DVT INCLUDE LEIOMYOSARCOMA AND MAY-THURNER SYNDROME. THE PATIENT WAS TREATED WITH 6 MONTHS OF XARELTO. SEG TM COLLAR IS THE ONLY TMT DESIGN CONTROLLED PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631854 STEM COLLAR 35 MM O.D. JWH ZIMMER TMT N/A 62738144

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention