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	Fever (1858); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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, SE-75 2 28; SW SE-752 28
• Manufacturer Contact: lizzie fields ; 4721 emperor blvd.; suite 100; durham, NC 27703 ; 9194746802
• MDR Report Key: 20578525
• Report Number: 3009595577-2024-00006
• Device Sequence Number: 12804633
• Product Code: MOZ
• UDI-Device Identifier: 00816986020808
• UDI-Public: (01)00816986020808(17)270131(10)22366
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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: 1082020
• Device Lot Number: 22366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• 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: EMCYTE PURE PRP KIT
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female