BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3862761 · Received May 27, 2014

    Report

    Report Number
    3003640913-2014-00039
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING; MODEL#: 400-140; LOT#: 0903117; EXPIRATION DATE: 06/01/2014; DATE OF IMPLANTATION: (B)(6) 2010; DATE OF EXPLANTATION; 04/17/2014; DEVICE MANUFACTURE DATE: 06/2009. STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT; MODEL#: 400/254; LOT#: 090303/0229; EXPIRATION DATE: 10/01/2014; DATE OF IMPLANTATION: (B)(6) 2010; DATE OF EXPLANTATION: (B)(6) 2014; DEVICE MANUFACTURE DATE: 10/2009. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-254, LOT NO. 090303/0229. THE DHR FOR PART NO. 400-263, LOT NO 090416/2491 NOTES THAT 12 OUT OF 20 PIECES WERE DISCARDED, AND 1 PIECE WAS REWORKED. THE DHR FOR PART NO 400-140 LOT NO 0903117 NOTES THAT 2 OUT OF 66 PIECES WERE DISCARDED. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT COMPONENTS WERE REMOVED DUE TO CYSTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311761 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-263 090416-2491

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention