BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 24646415 · Received March 19, 2026

    Report

    Report Number
    1644408-2026-00613
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    July 5, 2023
    Report Date
    March 19, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    NTG
    UDI-DI
    00886385027005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    POLY SWAP WITH OSTEOTOMY TO IMPROVE RANFGE OF MOTION AND ALIGNMENT. TRILLIANT SURGICAL IS THE MANUFACTURER OF THE DEVICE, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR AN INJURY THAT WAS LIFE THREATENING. A MALFUNCTION OF THE DEVICE RESULTING IN A FAILURE OF THE DEVICE TO PERFORM ITS ESSENTIAL FUNCTION WHICH COMPRISES THE DEVICE'S THERAPEUTIC EFFECTIVENESS THAT COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY DID NOT OCCUR. RECURRENCE OF THE MALFUNCTION IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THE DEVICE IS NOT CONSIDERED TO BE LIFE SUPPORTING OR LIFE SUSTAINING. THE DEVISE WAS NOT RETURNED FOR EVALUATION, AND ADDITIONAL INFORMATION WAS NOT RECEIVED REGARDING THE REASON FOR THE REVISION SURGERY. A ROOT CAUSE COULD NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    REVISION SURGERY - POLY SWAP WITH OSTEOTOMY TO IMPROVE RANFGE OF MOTION AND ALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707055 STAR REVISION SLIDING CORE STAR ANKLE 14MM NTG ENCORE MEDICAL L.P. UNKNOWN 00886385027005

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other