BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR TIBIAL COMPONENT.

    MDR report key: 5983929 · Received September 28, 2016

    Report

    Report Number
    0008031020-2016-00482
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    March 20, 2015
    Report Date
    September 9, 2016
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. 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 (B)(6) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    STAR ANKLE REPLACEMENT DONE. XLG SIZE FOR TIBIA, SM TALUS. IT IS JUST NOT SUCCESSFUL IN BENDING AT ALL AND HAS QUIT WORKING. IN FACT, NEVER HAS IT WORKED. PATIENT CLARIFIED THAT IT IS HER RIGHT ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636419 UNKNOWN STAR TIBIAL COMPONENT. PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention