BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TALAR COMPONENT

    MDR report key: 9908621 · Received March 31, 2020

    Report

    Report Number
    0008031020-2020-00937
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    January 1, 1999
    Report Date
    March 31, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS BEEN REPORTED DURING A LITERATURE REVIEW PERFORMED BY THE POST MARKET SURVEILLANCE GROUP. 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 A LITERATURE FROM (B)(6) UNITED STATES. THE TITLE OF THIS REPORT IS ¿INTERMEDIATE-TERM EXPERIENCE WITH THE STAR TOTAL ANKLE IN THE UNITED STATES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SCANDINAVIAN TOTAL ANKLE REPLACEMENT (STAR)¿ SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM JANUARY 1999 TO 2013. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE 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 76 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES FAILURE OF IMPLANT FOLLOWED BY ANKLE FUSION. 1 OUT OF 4 CASES. THE REPORT STATES: ¿FOUR OF THE 21 TOTAL FAILURES OCCURRED IN PATIENTS WHO UNDERWENT ELECTIVE EXPLANT AND TIBIOTALAR FUSION BECAUSE OF CONTINUED UNEXPLAINED ANKLE PAIN. NO SPECIFIC FAILURE MODE WAS ABLE TO BE DETERMINED AFTER REVIEW OF RADIOGRAPHS AND INTRAOPERATIVE FINDINGS AT THE TIME OF IMPLANT REMOVAL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372158 UNKNOWN TALAR COMPONENT IMPLANT NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention