BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3591179 · Received January 15, 2014

    Report

    Report Number
    3003640913-2014-00003
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    December 16, 2013
    Report Date
    January 2, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVISED COMPONENT: STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING. MODEL #: 400-142, LOT # 0945163. EXPIRATION DATE: 01/01/2015. DATE OF IMPLANTATION: (B)(6) 2012, DATE OF EXPLANTATION: (B)(6) 2013. DEVICE MFR DATE: 01/2010. ADDITIONAL REVISED COMPONENT: STAR TOTAL ANKLE REPLACEMENT. TALAR COMPONENT. MODEL # 400-254, LOT # 100304/2473. EXPIRATION DATE: 06/01/2015. DATE OF IMPLANTATION: (B)(6) 2012. DATE OF EXPLANTATION: (B)(6) 2013. DEVICE MFR DATE: 06/2010. PT HAD STAR TOTAL ANKLE REPLACEMENT REMOVED, AND ANKLE FUSED DUE TO PAIN/DEFORMITY. THE DHR FOR PART NO. 400-142 LOT # 0945163 SHOW NO ANOMALIES; THE DHR FOR PART NO. 400-262, LOT # 100114/0059 NOTE THAT (B)(4) PIECES WERE RE-WORKED; THE DHR FOR PART NO. 400-254, LOT # 100304/2473 NOTE THAT (B)(4) PIECES WERE RE-WORKED; ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    PT HAD STAR TOTAL ANKLE REPLACEMENT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39922 STAR TOTAL ANKLE REPLACEMENT TIBIAL COMPONENT NTG SMALL BONE INNOVATIONS, INC. 400-262 100114/0059

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention