BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR MOBILE BEARING

    MDR report key: 8527691 · Received April 18, 2019

    Report

    Report Number
    0008031020-2019-00361
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    May 1, 2014
    Report Date
    April 18, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITH GUIDANCE FROM THE MDR POLICY BRANCH OF THE FDA, MDR REPORTED BY STRYKER (B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM SMALL BONE INNOVATION, INC. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(4) 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. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE EVALUATED BY MFR: DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A STUDY FROM THE DEPARTMENT OF TRAUMA & ORTHOPAEDICS, ALTNAGELVIN HOSPITAL, NORTHERN IRELAND, UK. THE TITLE OF THIS STUDY IS ¿PRE-REQUISITES FOR OPTIMUM CENTERING OF A TIBIOTALOCALCANEAL ARTHRODESIS NAIL¿ AND IS ASSOCIATED WITH THE STAR ANKLE SYSTEM. THE STUDY PUBLISHED IN MAY 2014 REPORTED POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC PATIENT AND DEVICE INFORMATION FROM THE REPORT; A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENT HAS NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION. THEREFORE 1 COMPLAINT WAS INITIATED RETROSPECTIVELY FOR THE ADVERSE EVENT MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES FAILED TOTAL ANKLE REPLACEMENT. THE STUDY STATES: ¿THE THIRD PATIENT UNDERWENT TTC AFTER REMOVAL OF A FAILED TOTAL ANKLE REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322800 UNKNOWN STAR MOBILE BEARING PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention