BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN TALAR COMPONENT

    MDR report key: 9800880 · Received March 6, 2020

    Report

    Report Number
    0008031020-2020-00608
    Event Type
    Death
    Date Received
    March 6, 2020
    Date of Event
    November 1, 2001
    Report Date
    March 6, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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) HOSPITAL, (B)(6). THE TITLE OF THIS REPORT IS ¿INTERMEDIATE TO LONG-TERM OUTCOMES OF TOTAL ANKLE REPLACEMENT WITH THE SCANDINAVIAN TOTAL ANKLE REPLACEMENT (STAR)¿ 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 NOVEMBER 2001 TO OCTOBER 2005. 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 64 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DEATH. 3 OUT OF 6 CASES. THE REPORT STATES: ¿SIX PATIENTS (EACH WITH ONE PROSTHESIS) DIED, 3.8 TO 9.3 YEARS AFTER SURGERY.¿ CAUSE AND THE DATE OF THE DEATH IS UNKNOWN AND WILL NOT BE DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263478 UNKNOWN TALAR COMPONENT IMPLANT NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death