MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC; SYNOVIAL FLUID SUPPLEMENTATION MEDIUM

Catalog Number	690016
Medical Device Problem Codes	Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Back pain (4895)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 13june2025, a medwatch report was received from the fda.A 77-year-old female patient reported receiving a monovisc (lot number: unknown) injection (treatment course, knees) on or about on (b)(6) 2024.After receiving the injections, the patient reported experiencing back pain, and some ambulatory difficulty.There was no malfunction reported.Patient comorbidities are unknown.The current status of the patient is unknown.It is unknown if the patient received unplanned medical intervention.There was no contact information to obtain additional information from the patient or clinic.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 13june2025 a medwatch report was received from the fda.A 77-yearold female patient reported receiving a monovisc (lot number unknown) injection (treatment course, knees) on or about (b)(6) 2024.After receiving the injections, the patient reported experiencing back pain, and some ambulatory difficulty.There was no malfunction reported.Patient comorbidities are unknown.The current status of the patient is unknown.It is unknown if the patient received unplanned medical intervention.There was no contact information to obtain additional information from the patient or clinic.
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.Supplemental report: the cause of the reported event could not be established due to insufficient information.Additional information was not provided when solicited.A review of the batch record could not be performed; the lot number was not provided.A review of the stability study report was performed, and the conclusion is the product has met all required specifications and tolerances.A three-year retrospective review of retention inventory inspection reports was performed.There were no nonconformances documented in the report.A three-year retrospective review of all nonconformances was performed for this product.There was no nonconformances related to the reported event.However, causality could not be determined due to insufficient information provided.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored and trended for future analysis.

• Brand Name: MONOVISC
• Common Device Name: SYNOVIAL FLUID SUPPLEMENTATION MEDIUM
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: lee perloff ; 32 wiggins ave; bedford, MA 01730
• MDR Report Key: 22285987
• Report Number: 3007093114-2025-00007
• Device Sequence Number: 8373740
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 94 KG