BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3677165 · Received February 20, 2014

    Report

    Report Number
    3003640913-2014-00012
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    September 13, 2013
    Report Date
    January 24, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING MODEL #: 400-141, LOT #: 1147025, EXPIRATION DATE: 12/01/2016, DATE OF IMPLANTATION: (B)(6) 2013, DATE OF EXPLANTATION: (B)(6) 2013, DEVICE MANUFACTURE DATE: 12/2011. STAR TOTAL ANKLE REPLACEMENT , TALAR COMPONENT, MODEL #: 400-252, LOT #: 091204/2291, EXPIRATION DATE: 04/01/2015, DATE OF IMPLANTATION: (B)(6) 2013, DATE OF EXPLANATION: (B)(6) 2013, DEVICE MANUFACTURE DATE: 04/2015. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NUMBERS 400-141 LOT 1147025 OR 400-252 LOT 091204/2291. THE DHR FOR PART NO. 400-263 LOT 100325/0133 NOTED THAT 2 OUR OF THE 40 PIECES WERE DISCARDED, AND 10 PIECES WERE REWORKED; ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT, SLIDING CORE MOBILE BEARING, AND TALAR COMPONENT WAS REMOVED DUE TO AN OPEN WOUND INFECTION. AN ANTIBIOTIC SPACER WAS PUT IN PLACE UNTIL(B)(6) 2014 WHEN THE SURGEON REPLACED ALL THREE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106866 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 100325/0133

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention