BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN T2 KNEE ARTHRODESIS NAIL (T2 KAN)

    MDR report key: 21168622 · Received January 16, 2025

    Report

    Report Number
    0008031020-2025-00129
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    March 23, 2023
    Report Date
    January 16, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT THERE WAS A FAILURE OF THE DEVICE COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE PRESENT POST-MARKET CLINICAL FOLLOW-UP (PMCF) NAMED "POST-MARKET CLINICAL FOLLOW-UP OF STRYKER TRAUMA & EXTREMITY DEVICES: RETROSPECTIVE COHORT STUDY UTILIZING A US HEALTHCARE DATABASE: SAFETY AND PERFORMANCE OUTCOMES IN PATIENTS TREATED WITH T2 KNEE ARTHRODESIS NAILS" IS INTENDED TO PROVIDE ADDITIONAL CLINICAL DATA FROM THE REAL-WORLD USAGE OF THE IMPLANTS. THE STUDY IS DESIGNED AS A PMCF ACTIVITY THAT WILL PROVIDE PERFORMANCE AND SAFETY DATA ON T2 KAN IMPLANTS IN A REPRESENTATIVE POPULATION IN THE US. DURING THE REVIEW OF THE PMCF, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: FAILURE OF IMPLANT IN 1 CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791022 UNKNOWN T2 KNEE ARTHRODESIS NAIL (T2 KAN) ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other