BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3778335 · Received April 23, 2014

    Report

    Report Number
    3003640913-2014-00035
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 3, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING, MODEL #: 400-143, LOT #: 0940064, EXPIRATION DATE: 01/16/2012, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 02/2010. STAR TOTAL ANKLE REPLACEMENT: TALAR COMPONENT, MODEL #: 400-257, LOT #: 091204/2553, EXPIRATION DATE: 04/01/2015, DATE OF IMPLANTATION: (B)(6) 2012, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 04/2010. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-143, LOT NO. 0940064. THE DHR FOR PART NO. 400-257, LOT NO. 091204/2553 NOTES THAT (B)(4) PIECES WERE DISCARDED, AND (B)(4) PIECE WAS REWORKED. THE DHR FOR PART NO. 400-263, LOT NO. 100204/2639 NOTES THAT (B)(4) PIECES WERE REWORKED. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245339 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 100204/2639

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention