MAUDE Adverse Event Report: BIOVENTUS LLC SODIUM HYALURONATE (DUROLANE) 60 MG/3ML; ACID, HYALURONIC, INTRAARTICULAR

Lot Number	18302
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Two pts (one male, one female) had similar reactions to durolane viscosupplementation injection that were unexpected and uncommon.Patient #1 received 60 mg sodium hyaluronate injection in right knee on (b)(6) 2021.Patient returned to clinic on (b)(6) reporting worsening pain since injection.Patient #2 received 60 mg sodium hyaluronate injection in each knee also on (b)(6).Patient returned to clinic on (b)(6) with 0 minutes of relief since last injection and no improvement in symptoms.Appears medications were from the same lot.Suspect possible device malfunction due to unexpected absence of relief from symptoms for all three injections from same lot.

• Brand Name: SODIUM HYALURONATE (DUROLANE) 60 MG/3ML
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 11588416
• Report Number: MW5100356
• Device Sequence Number: 3511754
• Product Code: MOZ
• UDI-Device Identifier: 89130-2020-1
• UDI-Public: 89130-2020-1
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 02/26/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/31/2023
• Device Lot Number: 18302
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1