BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3524877 · Received November 20, 2013

    Report

    Report Number
    3003640913-2013-00055
    Event Type
    Injury
    Date Received
    November 20, 2013
    Date of Event
    October 29, 2013
    Report Date
    October 30, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVISED COMPONENT: STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING, MODEL# 400-142, LOT# 0950058, DEVICE MANUFACTURER DATE: 12/2010, EXPIRATION DATE: 12/01/2015, DATE IMPLANTATION: (B)(6) 2013, DATE OF EXPLANTATION: (B)(6) 2013. PATIENT HAD TIBIAL COMPONENT EXCHANGED DUE TO TIBIAL BONE LOSS AND TILT OF IMPLANT. SLIDING CORE MOBILE BEARING ALSO EXCHANGED. THE DHR FOR PART NO 400-142 LOT 0950058 SHOWS NO ANOMALIES; THE DHR FOR PART NO 400-262 LOT 100211/1906 NOTED THAT 4 OUT OF THE 40 PIECES WERE DISCARDED, AND 8 WERE REWORKED; ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    PATIENT HAD STAR TIBIAL COMPONENT AND SLIDING CORE MOBILE BEARING REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602695 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-262 100211/1906

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention