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

Lot Number 18302

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 02/12/2021

Event Type  malfunction  

Event 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
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 11588416
• MDR Text Key: 243142057
• Report Number: MW5100356
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130-2020-1
• UDI-Public: 89130-2020-1
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/26/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2023
• Device Lot Number: 18302
• Type of Device Usage: N
• Patient Sequence Number: 1