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	Unspecified Infection (1930)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case is still under investigation.Additional information was solicited.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 (b)(6) 2024 it was reported that after a patient of unknown age and demographic was treated with monovisc in the right knee the patient reportedly was unable to walk and reported pain.The patient was subsequently placed on a steroid (course / brand unknown) to treat the patient's infection.The patient also had 90cc of fluid drained a week after the injection.There was no report of any device or packaging deficiency prior to the treatment.Additional information was solicited.
Additional Manufacturer Narrative
This case is still under investigation.Additional information was solicited.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 reported event is not confirmed.Additional information was not provided upon request.A review of the batch record.There was no nonconformances related to to the reported event.The lot was manufactured and released to applicable procedures and specifications.A three year retrospective review of all nonconformances was performed.There are no nonconformances related to the reported event.A three year retrospective review of all retention inspection reports was performed.There was no nonconformances related to the reported event in the reports.A review of the recent stability study report for monovisc was performed.The conclusion for the product stated that the product has met all required specifications and tolerances.A clinical assessment of the complaint was performed by (b)(6), md.There was insufficient information to establish a temporal association between the use of the device and patient experience.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored 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 on this report.On 19december2024 it was reported that after a patient of unknown age and demographic was treated with monovisc in the right knee the patient reportedly was unable to walk and reported pain.The patient was subsequently placed on a steroid (course / brand unknown) to treat the patient's infection.The patient also had 90cc of fluid drained a week after the injection.There was no report of any device or packaging deficiency prior to the treatment.Additional information was solicited.
Additional Manufacturer Narrative
This case is still under investigation.Additional information was solicited.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 reported event is not confirmed.Additional information was not provided upon request.A review of the batch record.There was no nonconformances related to the reported event.The lot was manufactured and released to applicable procedures and specifications.A three-year retrospective review of all nonconformances was performed.There are no nonconformances related to the reported event.A three-year retrospective review of all retention inspection reports was performed.There was no nonconformances related to the reported event in the reports.A review of the recent stability study report for monovisc was performed.The conclusion for the product stated that the product has met all required specifications and tolerances.A clinical assessment of the complaint was performed by (b)(6), md.There was insufficient information to establish a temporal association between the use of the device and patient experience.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored trended for future analysis.Supplemental report #2: additional information was provided, the patient had additional fluid drained on (b)(6).The patient used oral steroids, type not reported.The patient had a mri on (b)(6).It was indicated that the patient has advanced arthritis.Patient was referred to infection disease and was re-admitted to the hospital on (b)(6) with a picc line to receive iv steroids.Patient is currently in rehab and using a walker.It was reported that the patient is improving with steroids.The case was reviewed by a clinician who concluded there is insufficient information to establish a cause of the reported incident.A supplemental report will be submitted upon receipt of new and relevant information.
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 (b)(6)2024 it was reported that after a patient of unknown age and demographic was treated with monovisc in the right knee the patient reportedly was unable to walk and reported pain.The patient was subsequently placed on a steroid (course / brand unknown) to treat the patient's infection.The patient also had 90cc of fluid drained a week after the injection.There was no report of any device or packaging deficiency prior to the treatment.Additional information was solicited.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 21112816
• Report Number: 3007093114-2025-00001
• Device Sequence Number: 8718949
• Product Code: MOZ
• UDI-Device Identifier: 00817337000104
• UDI-Public: 00817337000104
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

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
• Device Catalogue Number: 690016
• Device Lot Number: 0000010826
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/24/2025; 03/07/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/24/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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 Sex: Unknown