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

Catalog Number	690016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2025
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 in this report.On 10sep2025, the following was reported to anika via medwatch report number (mw5174193) event: patient reported she had gastric bypass surgery.Freq: inject 1 syringe intra-articularly into the right knee once.It was indicated that monovisc was used for the procedure.The device is not available for evaluation.There was no malfunction reported.The current status of the patient is unknown.It is unknown if the patient received unplanned medical intervention.
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 10sep2025 the following was reported to anika via medwatch report number (mw5174193) event: patient reported she had gastric bypass surgery.Freq: inject 1 syringe intra-articularly into the right knee once.It was indicated that monovisc was used for the procedure.The device is not available for evaluation.There was no malfunction reported.The current status of the patient is unknown.It is unknown if the patient received unplanned medical intervention.
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: based on the reported event, it is not expected that the product was related to the event.No harm was reported.The problem could not be confirmed, and the root cause could not be determined.On 10sep2025 the following was reported via medwatch report number mw5174193: a pharmacist indicated that a patient reported a 62-year-old, female had gastric bypass surgery.She was injected with 1 syringe intra-articularly into the right knee once.It was indicated that monovisc 88 mg/4ml (4=1 syr) (monovisc 4 ml us - 690016, lot number 0000010924) was used for the procedure.The device is not available for evaluation.Concomitant medical products and other treatments include ambien tab 10 mg, amlodipine tab 5mg, aprepitant cap 80mg, ativan tab 0.5mg, benzonatate cap 100 mg, doxycycl hyc cap 20 mg dr, duloxetine cap 20mg dr, eliquis tab 2.5mg, flonase algy spr 50mcg, gabapentin cap 300mg.The device was not available for return.In addition, it was reported that the patient was female.Medical professional determined that the patient's experience is not related to the use of the device.No other additional information was available to provide, and all available information was reported on initial report.Reviewed the batch record for lot 0000010924.Udi (b)(4).Manufacture date: 24apr2024.Expiration date 24apr2027.There were no nonconformances related to the reported event.The lot was manufactured and released to applicable procedures and specifications.A three-year retrospective review of the ncrs this product was performed.There were no nonconformances documented that could be related to the reported event.The ifu was reviewed: warnings, temperature storage, handling precautions, and general device-specific information are sufficiently documented in the ifu.A review of retention inspection logs for lot number 0000010924 was performed.Visual appearance was listed as good clear gel.There was no nonconformances documented in the logs that is related to the reported event.A review of the recent stability study report for monovisc was performed.There were no non-conformances documented.The conclusion for the product stated that the product has met all required specifications the data in the report shows that the stability profiles of the annual lots are consistent and indicate that the process is stable.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: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: lee perloff ; 32 wiggins ave; bedford, MA 01730
• MDR Report Key: 23209352
• Report Number: 3007093114-2025-00011
• Device Sequence Number: 13120059
• Product Code: MOZ
• UDI-Device Identifier: 00817337000104
• UDI-Public: 00817337000104
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 690016
• Device Lot Number: 0000010924
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 02/18/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female