BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3221518 · Received July 9, 2013

    Report

    Report Number
    3003640913-2013-00029
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 9, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    HSN
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD STAR SLIDING CORE BEARING COMPONENT REVISED AFTER 2.5 YEARS OF IMPLANTATION. COMPANY REPORT FORM INDICATES POLY WAS FRACTURED. REVIEW OF MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    PATIENT HAD STAR SLIDING CORE BEARING REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312697 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE HSN SMALL BONE INNOVATIONS, INC. 400-143 0912076

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention GUTTER DEBRIDEMENT