BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3676810 · Received February 27, 2014

    Report

    Report Number
    3003640913-2014-00018
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 29, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING, MODEL #: 400-140, LOT #: 1010028, EXPIRATION DATE: 11/01/2015, DATE OF IMPLANTATION: (B)(6) 2011, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 11/2010; STAR TOTAL ANKLE REPLACEMENT, TALAR COMPONENT, MODEL #: 400-254, LOT #: 091002/2004, EXPIRATION DATE: 01/01/2015, DATE OF IMPLANTATION: (B)(6) 2011, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 01/2010. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NUMBERS 400-140 LOT 1010028, OR 400-254 LOT 091002/2004. THE DHR FOR PART NO. 400-263 LOT 100204/2832 NOTED THAT 1) OUT OF THE 35 PIECES WERE DISCARDED, AND 5 PIECES WERE REWORKED; ALL RELEASED PARTS WERE WITHIN SPECIFICATION. VISUAL EXAMINATION CONFIRMS MARKS ON THE COMPONENTS ARE CONSISTENT WITH INSIGNIFICANT WEAR AND REMOVAL OF COMPONENTS. COMPANY REPORT FORM ALSO STATES SURGEON DAMAGED IMPLANTS UPON REMOVAL.

    Description of Event or Problem · 1

    THE STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT, SLIDING CORE MOBILE BEARING, AND TALAR COMPONENT WAS REMOVED DUE TO MEDIAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120875 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 100204/2832

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention