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

Catalog Number	630254
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907)
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 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) 2025, it was reported to anika that after receiving an orthovisc injection, the patient had a pseudoseptic reaction to orthovisc.The patient's knee was then aspirated and tested positive for streptococcous mitis oralis.The device is not available for evaluation.There was no malfunction reported.The current status of the patient is unknown.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.A supplier reported that a patient experienced a knee reaction initially described as a pseudoseptic reaction; however, aspiration of the knee was positive for streptococcus mitis/oralis, supporting septic arthritis rather than pseudosepsis.The device was not available for return, but the lot was confirmed.A batch record review was completed for the reported lot.No nonconformances or deviations were documented, all tested characteristics were within specification, and the lot was manufactured and released according to applicable procedures and specifications.A three-year retrospective review of nonconformance records identified a nonconformance initiated for an increase trend in complaint rate determined over 3 consecutive months for transient pain trend in 2024.The ifu was reviewed and was found to sufficiently document warnings, storage conditions, handling precautions, and general device-specific information, including that injections should not be administered in the presence of infection or skin disease around the injection site.A review of retention inspections completed over the prior three years found no nonconformances related to the reported event.A review of the recent stability study found no related nonconformances or out-of-specification investigations and concluded that annual lot stability profiles were consistent, indicating a stable process.Clinical assessment concluded that the event is more consistent with septic arthritis than pseudoseptic reaction.Oral streptococcal species were noted to be a rare but serious cause of septic arthritis, and possible contributing factors may include unsafe injection practice or contamination from oral bacteria; however, there was insufficient information to determine a root cause.A temporal association was identified between the reported incident and use of the product.Relevant risk documentation for infection and pain requiring medical intervention was reviewed, and post-mitigated risk levels were identified as low to moderate.This case will continue to be monitored and trended for future analysis.
Event or Problem Description
This report is being submitted 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) 2025, it was reported to anika that after receiving an orthovisc injection, the patient had a pseudoseptic reaction to orthovisc.The patient's knee was then aspirated and tested positive for streptococcous mitis oralis.The device is not available for evaluation.There was no malfunction reported.The current status of the patient is unknown.Additional information is being solicited.

• Brand Name: ORTHOVISC
• 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 avenue; bedford, MA 01730
• MDR Report Key: 23329798
• Report Number: 3007093114-2025-00015
• Device Sequence Number: 9845408
• Product Code: MOZ
• UDI-Device Identifier: 00817337000111
• UDI-Public: 00817337000111
• 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
• Report Date (Section B): 05/15/2026

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: 630254
• Device Lot Number: 0000012185
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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; Other
• Patient Sex: Unknown