BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROLANE

    MDR report key: 20578525 · Received October 31, 2024

    Report

    Report Number
    3009595577-2024-00006
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 30, 2024
    Manufacturer
    BIOVENTUS LLC
    Product Code
    MOZ
    UDI-DI
    00816986020808
    PMA / PMN Number
    P170007/S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF INFECTION FOLLOWING A CONCOMITANT INJECTION OF DUROLANE AND PRP WAS REVIEWED AND A ROOT CAUSE CANNOT BE ESTABLISHED. THE PROCEDURE OF THE PATIENT HAVING BLOOD REMOVED FROM THEIR BODY, PROCESSED AND REINJECTED IN THE KNEE POSES AN ADDITIONAL RISK OF INFECTION. MULTIPLE ATTEMPTS WERE COMPLETED FOR ADDITIONAL INFORMATION AND THE TYPE OF MICROBE IDENTIFIED IN THE CULTURES WAS NOT PROVIDED. THE PATIENT HAS RECOVERED AND IS UNDERGOING PHYSICAL THERAPY. A MEDICAL REVIEW WAS COMPLETED AND CONFIRMS PRODUCT LABELING DOES IDENTIFY THE POSSIBLE RISK OF INFECTION AND INSTRUCTS HEALTH CARE PROFESSIONALS TO UTILIZE PROPER ASEPTIC INJECTION TECHNIQUES WHEN ADMINISTERING THE PRODUCT. BASED ON THE LIMITED INFORMATION PROVIDED IT IS UNKNOWN IF THE EVENT IS RELATED TO THE DUROLANE PRODUCT, A POTENTIAL CONTRIBUTING FACTOR IS IMPROPER INJECTION TECHNIQUE AND/OR IMPROPER ASEPTIC INJECTION TECHNIQUE. NO ADDITIONAL RISK TO THE PATIENT OR USER HAS BEEN IDENTIFIED, NO ADDITIONAL ACTION WILL BE COMPLETED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. BIOVENTUS WILL CONTINUE TO MONITOR THIS AND SIMILAR EVENTS SHOULD FURTHER ACTION BE REQUIRED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT WAS INITIALLY INJECTED ON (B)(6) 2024, CONCOMITANTLY WITH DUROLANE AND A PLATELET-RICH PLASMA (PRP) INJECTION TO THE LEFT KNEE. ONE DAY POST INJECTION THE PATIENT EXPERIENCED; PAIN, SWELLING, FEVER AND REDNESS AT THE INJECTION SITE. THE PATIENT WENT IN FOR A FOLLOW UP VISIT TWO DAYS POST PROCEDURE. DURING THE FOLLOW UP VISIT THE PATIENTS' KNEE WAS ASPIRATED FOR CULTURES. THE CULTURES SHOWED POSITIVE RESULTS FOR INFECTION AND PATIENT WAS DIAGNOSED WITH SEPTIC ARTHRITIS. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 AND UNDERWENT A WASHOUT PROCEDURE. THE PATIENT UPON ADMISSION WAS STARTED ON INTRAVENOUS VANCOMYCIN AND PRIOR TO DISCHARGE THE PATIENT WAS PRESCRIBED DOXYCYCLINE. THE PATIENT WAS DISCHARGED AFTER FOUR DAYS AND THE CURRENT PATIENT STATUS IS RECOVERED AND UNDERGOING PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067092 DUROLANE HYALURONIC ACID MOZ BIOVENTUS LLC N/A 22366 00816986020808

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| H EMCYTE PURE PRP KIT