MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. 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	Cyanosis (1798); Arthralgia (2355); Swelling/ Edema (4577); Limb Pain (4836)
Date of Event	04/04/2025
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 (b)(6) or its employees that the report constitutes an admission that the device, (b)(6), or its employees, caused or contributed to a potential patient event documented in this report.On 11feb2026, the distributor reported the following to anika: we received an anika product complaint with the following event description as reported to j&j medtech orthopedics on 09-feb-2026.Event date was 04apr2025.(b)(6) 2 ml us - 630254: lot number unknown.The device return is unknown.Event description: patient states that he has orthovisc in the past without difficulty or reaction.Patient had orthovisc in both knees.After receiving the 3rd injection, the right knee was extremely swollen and painful.Patient reports that his lower right extremity - from knee down to foot began turning colors.Physician went ahead and gave the 4th injection.Patient states that he began having joint pain in bilateral knees, hips and shoulders and he has been to many docs and been tested for everything and docs are not able to make diagnosis.He had the right knee drained twice and the fluid came back clear.Patient states that he is in constant agony and takes 4-5 hydrocodone 10mg tablets per day along with oral steroid prednisone.Additional information is being solicited.
Additional Manufacturer Narrative
The case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at 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 (b)(6) 2026, the distributor reported the following to anika: we received an anika product complaint with the following event description as reported to j&j medtech orthopedics on 09-feb-2026.Event date was 04 apr 2025.Mitek orthovisc 2 ml us - 630254: lot number unknown.The device return is unknown.Event description: patient states that he has orthovisc in the past without difficulty or reaction.Patient had orthovisc in both knees.After receiving the 3rd injection, the right knee was extremely swollen and painful.Patient reports that his lower right extremity - from knee down to foot began turning colors.Physician went ahead and gave the 4th injection.Patient states that he began having joint pain in bilateral knees, hips and shoulders and he has been to many docs and been tested for everything and docs are not able to make diagnosis.He had the right knee drained twice and the fluid came back clear.Patient states that he is in constant agony and takes 4-5 hydrocodone 10mg tablets per day along with oral steroid prednisone.Additional information is being solicited.
Additional Manufacturer Narrative
The case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at the manufacturing plant.A distributor indicated that a patient previously received orthovisc injections without difficulty, then after a subsequent series (in both knees) reported severe right knee swelling and pain after the third injection and later developed ongoing joint pain involving both knees, hips, and shoulders.The patient reported discoloration of the lower right extremity, two right-knee aspirations with clear fluid, and ongoing treatment with hydrocodone and oral prednisone.No product was returned and the lot number was not provided; therefore, the batch record could not be reviewed.Nonconformance initiated an increase trend in complaint rate determined over 3 consecutive months for transient pain trend in 2024.The ifu was reviewed and warnings, storage temperature, handling precautions, and general device information were determined to be sufficiently documented.A review of the orthovisc stability study report did not identify related nonconformances or out-of-specification investigations and concluded annual lot stability profiles were consistent, indicating a stable process.Clinical assessment determined there is a temporal association between orthovisc injection and the reported right knee pain/swelling, which is a known inherent risk of the device; however, the complaint could not be confirmed and the available information was insufficient to assess whether the ongoing multi-joint symptoms were related versus progression of underlying osteoarthritis.Risk documentation was reviewed and post-mitigated risks were identified as low to moderate.A supplemental report will be submitted upon receipt of new and relevant informations.This case will be monitored and trended for future analysis.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: lee perloff ; 32 wiggins ave; bedford, MA 01730
• MDR Report Key: 24460661
• Report Number: 3007093114-2026-00007
• Device Sequence Number: 21158232
• Product Code: MOZ
• 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): 05/08/2026

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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: Required Intervention
• Patient Sex: Unknown