BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3720599 · Received March 24, 2014

    Report

    Report Number
    3003640913-2014-00026
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING, MODEL #: 400-141, LOT#: 1031065, EXPIRATION DATE: 01/01/2018, DATE OF IMPLANTATION: (B)(6) 2013, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 01/2013. STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING, MODEL #: 400-255, LOT #: 070597/709, EXPIRATION DATE: 11/15/2003, DATE OF IMPLANTATION: (B)(6) 1999, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 11/1998. THERE WERE NO DEVIATIONS REPORTED IN THE DHRS FOR PART NUMBERS 400-262 LOT 120399/61 OR 400/255 LOT 1031065 NOTES THAT 2 OUT OF THE 62 PIECES WERE DISCARDED; ALL RELEASED PARTS WERE WITHIN SPECIFICATION. COMPANY REPORT FORM STATES PATIENT WENT FROM (B)(6) AT TIME OF PRIMARY TO (B)(6) AT TIME OF EXPLANTATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT COMPONENTS WERE REMOVED DUE TO THE SUBSIDENCE OF THE TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171858 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-262 120399/61

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention