MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE; HYALURONIC ACID

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Bacterial Infection (1735); Pain (1994)
Date of Event	02/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient injected with durolane was diagnosed with septic arthritis and hospitalized.Patient was treated with antibiotics (clindamycine, cloxacilline) and morphine.This was the patient's first durolane injection, in which they were also injected with a steroid (diprostene) concomitantly.The patient was released and is recovering from the event.A batch record review was completed and confirmed this lot met all specifications prior to release.A review of reported durolane events identified two additional cases of infection with the same lot; however, all three cases were from the same facility and the injections performed by the same physician on the same day.Multiple follow-ups were completed for additional informaiton, and only limited information was provided and already included in this report.This event was reviewed by a clinical specialist who concluded a root cause could not be determined, and most likely due to the treatment procedure.Durolane labeling does identify infections as a potential adverse event with the use of the product.Bioventus will continue to monitor this and similar events should additional action be needed.
Event or Problem Description
It was reported that a patient being treated for moderate gonarthrosis of the knee was initially injected on (b)(6) 2025, concomitantly with durolane and a steroid injection.It was reported the physician used the same needle for the durolane injection that was utilized for the steroid injection.One day post injection, the patient experienced severe pain and swelling and was hospitalized.An aspiration procedure was completed as well as a joint puncture for bacterial sampling.The patient was diagnosed with septic arthritis caused by staphylococcus aureus.Patient was provided one intravenous and two oral antibiotics as well as morphine.The patient was discharged from the hospital on (b)(6) 2025 in stable condition.Patient has discontinued morphine and is reported to be improving with the use of the antibiotics.

• Brand Name: DUROLANE
• Common Device Name: HYALURONIC ACID
• Manufacturer (Section D): BIOVENTUS LLC; 4721 emperor blvd; suite 100; durham NC 27703
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala, swe SE-75 2 28; SW SE-752 28
• Manufacturer Contact: lizzie fields ; 4721 emperor blvd; suite 100; durham, NC 27703 ; 9194746802
• MDR Report Key: 21663766
• Report Number: 3009595577-2025-00002
• Device Sequence Number: 18035927
• Product Code: MOZ
• UDI-Device Identifier: 00816986020808
• UDI-Public: (01)00816986020808(17)270430(10)22587
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P170007/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: 22587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIPROSTENE INJECTION; SIMPONI
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female