BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR TIBIAL COMPONENT

    MDR report key: 7374386 · Received March 27, 2018

    Report

    Report Number
    0008031020-2018-00233
    Event Type
    Injury
    Date Received
    March 27, 2018
    Date of Event
    July 15, 2014
    Report Date
    March 27, 2018
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY (B)(4) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF (B)(4) ON AUGUST 1, 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    THE REVIEW OF THE NATIONAL JOINT REPLACEMENT REGISTRY OF THE (B)(6) ORTHOPEDIC ASSOCIATION REVEALED A STAR ANKLE REVISION SURGERY DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218793 UNKNOWN STAR TIBIAL COMPONENT PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention