BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4147233 · Received October 2, 2014

    Report

    Report Number
    3003640913-2014-00071
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING, MODEL# 40-141, LOT# 0939102, EXPIRATION DATE 12/01/2016, DEVICE MANUFACTURE DATE 12/01/2011; TALAR COMPONENT, MODEL# 400-255, LOT# 091204/1600, EXPIRATION DATE 04/01/2015, DEVICE MANUFACTURE DATE 04/01/2010. THE DHR FOR PART NO 400-262, LOT NO 100114/0288 NOTES THAT 3 OUT OF 40 PIECES WERE DISCARDED. THE DHRS FOR BOTH PART NO 400-255, LOT 091204/1600 AND PART NO 400-141 LOT NO 0939102 SHOW NO DEVIATIONS. ALL RELEASED PARTS WERE WITHIN SPECIFICATION. REVIEW OF THE PT'S RADIOGRAPHIC IMAGES NOTES THE REPAIR OF THE FRACTURED MEDIAL MALLEOLUS WAS UNSUCCESSFUL RESULTING IN ANKLE INSTABILITY. VISUAL EXAMINATION OF THE EXPLANTED DEVICE CONFIRMS WEAR CONSISTED WITH AN UNSTABLE ANKLE AND REMOVAL MARKS.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SYSTEM WAS REMOVED AND PT'S ANKLE WAS REVISED TO FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615432 STAR TOTAL ANKLE REPLACEMENT NTG SMALL BONE INNOVATIONS, INC. 400-262 100114-0288

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention