MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE; ACID, HYALURONIC, INTRAARTICULAR

Model Number	1082020
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On [date redacted] pt received a durolane injection to the l [left] knee in the [redacted] orthopedic office.No immediate complications were noted post-injection.On [date redacted] -- 2 days after injection, the pt called the office reporting he was experiencing swelling, inability to weight bear, and extreme pain.Pt reported was resting the knee, using ice, elevating the extremity, and taking/exceeding the normal amount of advil without relief.

• Brand Name: DUROLANE
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC; 4721 emperor blvd ste 100; durham NC 27703
• MDR Report Key: 22529904
• Report Number: 22529904
• Device Sequence Number: 18125830
• Product Code: MOZ
• UDI-Device Identifier: 00816986020808
• UDI-Public: (01)00816986020808
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/11/2025
• Report Date (Section F): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1082020
• Device Catalogue Number: 1082020
• Device Lot Number: 23172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 07/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Date Report Sent to FDA: 07/11/2025