BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4024279 · Received August 13, 2014

    Report

    Report Number
    3003640913-2014-00055
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 30, 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

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING, MODEL #400-141, LOT: 0921074, EXP DATE: 03/01/2015. DEVICE MFR DATE: 03/01/2010. TIBIAL COMPONENT,: MODEL # 400-263, LOT# 100318/3620, EXP DATE: 07/01/2014, DEVICE MFR DATE: 07/01/2010. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-141, LOT NO. 0921074. THE DHR FOR PART NO. 400-256, LOT NO. 100107/4095 NOTES THAT 2 OUT OF THE 40 PIECES WERE..., AND THE DHR FOR PART NO. 400-263, LOT NO. 100318/3620 NOTES THAT 1 PIECE OUT OF 40... ALL RELEASED PARTS WERE WITHIN SPECIFICATION. COMPANY REPORT FORM INDICATES PATIENT'S OVER ACTIVITY CONTRIBUTED TO THE PATIENT'S ANKLE DEFECTS. VISUAL EXAMINATION NOTES THAT METAL COMPONENTS WERE WELL FIXED WITH NORMAL BEARING SURFACES. SLIDING CORE SHOWS NO SIGNIFICANT WEAR.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SYSTEM WAS REMOVED AND PATIENT'S ANKLE WAS REVISED WITH ANOTHER PRODUCT DUE TO CYSTIC LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482922 STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-256 100107/4095

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention