BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR ANKLE

    MDR report key: 6687403 · Received July 5, 2017

    Report

    Report Number
    0008031020-2017-00384
    Event Type
    Injury
    Date Received
    July 5, 2017
    Date of Event
    December 16, 2013
    Report Date
    July 5, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON AUGUST 1, 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT CALLED COMPLAINING OF PAIN IN RIGHT ANKLE, HAD TOTAL ANKLE REPLACEMENT (B)(6) 2013. WENT TO ANOTHER DOCTOR REMOVED CYST'S. ALSO INQUIRING ABOUT RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469131 UNKNOWN STAR ANKLE PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention