BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR POLYETHYLENE COMPONENT

    MDR report key: 10051947 · Received May 13, 2020

    Report

    Report Number
    0008031020-2020-01481
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    January 1, 2018
    Report Date
    May 13, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ¿THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(4) AND IMPLANTED BEFORE STRYKER BECAME THE LEGAL MANUFACTURER. ON APRIL 1, 2015 STRYKER BECAME THE LEGAL MANUFACTURER OF THE STAR SYSTEM AND HAS TAKEN THE RESPONSIBILITY FOR THE MEDICAL DEVICE REPORTING.¿ DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF STUDY FROM DUKE UNIVERSITY MEDICAL CENTER, USA. THE TITLE OF THIS REPORT IS ¿RISK FACTORS FOR FAILURE OF TOTAL ANKLE ARTHROPLASTY WITH A MINIMUM FIVE YEARS OF FOLLOW-UP¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿STAR¿ SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM JUNE 2007 TO APRIL 2013. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE/PATIENT DETAILS FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 5 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT AND THE STUDY WERE AVAILABLE AT HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/30345818. THIS PRODUCT INQUIRY ADDRESSES FAILURE OF STAR FOLLOWED BY REVISION SURGERY. 1 OUT OF 4 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514911 UNKNOWN STAR POLYETHYLENE COMPONENT IMPLANT NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention