MAUDE Adverse Event Report: Anika Therapeutics, Inc. Monovisc; Synovial fluid supplementation medium

Catalog Number	690016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Loss of Range of Motion (2032); Injection Site Reaction (4562); Swelling/ Edema (4577)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A distributor reported a monovisc related event involving a patient with a pseudoseptic reaction, reporting stiffness and swelling after knee injections.The device was discarded and was not available for return.The event was reported to have occurred in an unknown amount of days post knee injection.Patient outcome or consequences were indicated, but additional medical intervention, and whether revision surgery or hardware removal was required is unknown.Reported complaint terms included swelling, musculoskeletal stiffness, infection, and minor injury.This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

• Brand Name: Monovisc
• Common Device Name: Synovial fluid supplementation medium
• Manufacturer (Section D): Anika Therapeutics, Inc.; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: heather iwaniuk ; 32 wiggins ave; bedford, MA 01730
• MDR Report Key: 50368107
• Report Number: 3007093114-2026-00022
• Device Sequence Number: 21497897
• Product Code: MOZ
• UDI-Device Identifier: 00817337000104
• UDI-Public: (01)00817337000104(17)290415(10)0000014228
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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 Catalogue Number: 690016
• Device Lot Number: 0000014228
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown