BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3524878 · Received November 20, 2013

    Report

    Report Number
    3003640913-2013-00054
    Event Type
    Injury
    Date Received
    November 20, 2013
    Date of Event
    October 22, 2013
    Report Date
    October 23, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVISED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT, MODEL# 400-262, LOT# 100318/3373, DEVICE MANUFACTURER DATE: 07/2010, EXPIRATION DATE: 07/01/2015, DATE IMPLANTATION: (B)(6) 2013, DATE OF EXPLANTATION: (B)(6) 2013. STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING, MODEL# 400-142, LOT# 0933117, DEVICE MANUFACTURER DATE: 12/2010, EXPIRATION DATE: 12/01/2015, DATE IMPLANTATION: (B)(6) 2013, DATE OF EXPLANTATION: (B)(6) 2013. PATIENT HAD STAR TOTAL ANKLE REPLACEMENT SYSTEM REMOVED AND REVISED TO FUSION. COMPANY REPORT FORM INDICATES THAT THE PATIENT'S TALUS SUBSIDES AND THE TALUS BONE WAS DEAD. (B)(4); ALL PARTS WERE RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT HAD STAR TOTAL ANKLE REPLACEMENT SYSTEM REVISED AND ANKLE FUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602995 STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-252 091013/0616

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention