BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TIGHTROPE RT

    MDR report key: 21396936 · Received February 18, 2025

    Report

    Report Number
    1220246-2025-00491
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 30, 2025
    Report Date
    February 27, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    PMA / PMN Number
    K241235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT SURGERY IN (B)(6) 2020. IT WAS FURTHER REPORTED THAT TWO TITANIUM PLATES WERE INSERTED INTO THE KNEE. THE PATIENT REPORTED THAT POST OPERATION THE PATIENT GOT A SERIOUS REACTION AND STRONG INFECTION, WHICH THEN TRIGGERED AN AUTOIMMUNE DISEASE. NO FURTHER INFORMATION WAS PROVIDED. UPDATE DW (B)(6) 2025: FURTHER INFORMATION WAS PROVIDED THAT AN AR-1588RT WAS IMPLANTED INTO THE PATIENT. IT WAS FURTHER REPORTED THAT THE SURGEON HAS NO SUSPICION THAT THE THE DEVICE IS THE TRIGGER FOR THE AUTOIMMUNE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478035 ACL TIGHTROPE RT SMOOTH FIXATION PIN MBI ARTHREX, INC. ACL TIGHTROPE RT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other