MAUDE Adverse Event Report: ANIKA MONOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION

Catalog Number	690016
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Unspecified Nervous System Problem (4426)
Type of Reportable Event	Serious Injury
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 in this report.On (b)(6) 2026, the distributor reported the following to anika we received an anika product complaint with the following event description event date was unknown for monovisc 4 ml us - (b)(6) lot number unknown.The device return is unknown.Event description: patient states they have a pinched nerve.Patient feels nerve issue improved but have no cartlidge-bone on bone.Doctor injected pt with monovisc.Pt has problems with mobility and pain.After injection they experienced pain, a fall, went to er and walked around 6-8 months, no cartlidge left.Additional information is being solicited.
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.
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.Followup: the reporter described a patient with a history of knee osteoarthritis who received an intra-articular injection and subsequently experienced ongoing pain and mobility issues, with a reported fall and emergency evaluation; the event date was not provided and the product was not returned.Because the lot information was not provided, batch record review could not be performed; however, the product is manufactured and released to applicable procedures and specifications.A three-year retrospective review of nonconformance records and retention inspection records found no issues related to the reported event.The instructions for use were reviewed and were considered to sufficiently document warnings, storage and handling precautions, and potential adverse reactions, including transient pain, swelling, heat, rash/itching, bruising, and redness.A clinical assessment indicated the reported symptoms were most consistent with the underlying disease state and lack of treatment benefit rather than a product-related effect; therefore, a causal relationship could not be established, the complaint could not be confirmed due to limited information, and the event will continue to be monitored and trended for future analysis.
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 in this report.On 05feb2026, the distributor reported the following to anika we received an anika product complaint with the following event description event date was unknown for monovisc 4 ml us - 690016 lot number unknown.The device return is unknown.Event description: patient states they have a pinched nerve.Patient feels nerve issue improved but have no cartlidge-bone on bone.Doctor injected pt with monovisc.Pt has problems with mobility and pain.After injection they experienced pain, a fall, went to er and walked around 6-8 months, no cartlidge left.Additional information is being solicited.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: lee perloff ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 24414643
• Report Number: 3007093114-2026-00006
• Device Sequence Number: 5879671
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown