BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BTB TIGHTROPE

    MDR report key: 10308353 · Received July 22, 2020

    Report

    Report Number
    1220246-2020-01965
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 12, 2020
    Report Date
    July 22, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTY
    UDI-DI
    00888867019515
    PMA / PMN Number
    K112990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A REVISION ACL PROCEDURE ON 6/12/20. DURING THE PROCEDURE A LIFENET FGL WAS USED. PATIENT HAD DEVELOPED AN INFECTION. SURGEON WASHED OUT THE KNEE. SO FAR NOTHING HAS GROWN ON CULTURES, BUT HE WILL HAVE TO TAKE THE ALLOGRAFT OUT IF THE PATIENT DOESN¿T GET BETTER. THE REPORTER ALSO COPIED LIFENET IN ON THEIR INITIAL REPORT TO ARTHREX. GRAFT ID: 1913080-1009. ADDITIONAL INFORMATION PROVIDED ON 7/8/2020: THE PHYSICIAN REPORTED THE PATIENT HAD A PRIOR ACL SURGERY MANY YEARS AGO (>7) AND A REVISION WAS PERFORMED ON (B)(6) 2020. NO EVIDENCE OF ANY PRIOR OSTEO OR INFECTION IN THE PAST. THE PRIMARY SURGERY WAS PERFORMED BY A DIFFERENT SURGEON. THE SURGEON CANNOT CONFIRM IF ARTHREX PRODUCTS WERE USED DURING THE PRIMARY PROCEDURE. THE PATIENT DECIDED TO HAVE IT FINALLY REVISED, BUT HAD BEEN LIVING WITHOUT THEIR ACL FOR AWHILE. THE INDEX REVISION ACL SURGERY WAS ON (B)(6) 2020. WASHOUT WAS PERFORMED ONE WEEK LATER ON (B)(6) 2020. NO IMPLANTS WERE EXPLANTED AT THE TIME OF THE WASHOUT. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE REVISION SURGERY; FGL // GRAFT ID: 1913080-1009. AR-1588TN-1 // LOT: 10655198. AR-1588BTB // LOT: 10591147. AR-2270 // LOT: 10779787. FOLLOWING THE REVISION SURGERY; THE PATIENTS SYMPTOMS WERE FEVERS, NIGHT SWEATS AND FEELING ILL, MALAISE, WEIGHT LOSS, KNEE PAIN AND EFFUSION. THE PATIENT HAD ELEVATED ESR AND CRP. SOME BACTERIA NOTED IN THE CELL COUNT BUT NEVER GREW ANYTHING FROM ALL THE MULTIPLE CULTURES. THE PATIENT RESPONDED BETTER TO IV ABX WITH CEFTRIAXONE VIA A PICC LINE. THE PATIENT IS DOING BETTER, BUT STILL HAVING SOME NIGHT SWEATS. KNEE IS LOOKING AND FEELING BETTER. DUE TO THE UNUSUAL PRESENTATION AND LACK OF CULTURE RESULTS, THE SURGEON AND THE ID CONSULTANTS ARE CONCERNED ABOUT POSSIBLE CONTAMINATED GRAFT OR POSSIBLE MYCOBACTERIA, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775840 BTB TIGHTROPE PIN, FIXATION, SMOOTH HTY ARTHREX, INC. BTB TIGHTROPE 10591147 00888867019515

    Patients

    Seq Age Sex Outcome Treatment
    1 Other