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

Catalog Number 690016

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Pain (1994)

Event Date 01/23/2024

Event Type  Injury  

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 at the manufacturing plant.

Event 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 09feb2024 anika received a medwatch (mw 5150748) from the fda.A female patient of unknown age and demographics reported being injected with monovisc in (b)(6) 2024 and after ~5 hours after the injection, reported that her knee locked up and was painful.The patient reported that after ~7 hours experiencing chills and a 103-degree fever.The patient reported that 24 hours after the injection, still having ~101-degree fever.That patient reported at the time of submitting the medwatch that the fever improved and the knee doing is better.The patient did not report any medical intervention being provided or lab results confirming any infection.There was no report of any malfunction or issues with appearance with the device or packaging.The current status of the patient is unknown.Additional information was solicited.

Event 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 09feb2024 anika received a medwatch (mw 5150748) from the fda.A female patient of unknown age and demographics reported being injected with monovisc in january 2024 and after ~5 hours after the injection, reported that her knee locked up and was painful.The patient reported that after ~7 hours experiencing chills and a 103-degree fever.The patient reported that 24 hours after the injection, still having ~101-degree fever.That patient reported at the time of submitting the medwatch that the fever improved and the knee doing is better.The patient did not report any medical intervention being provided or lab results confirming any infection.There was no report of any malfunction or issues with appearance with the device or packaging.The current status of the patient is unknown.Additional information was solicited.

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 at the manufactuing plant.Supplemental report: the reported event could not be confirmed due to insufficient information being provided.It was reported that a patient of unknown age and demographics received a monovisc injection (lot and dosages unknown) in the left knee.The patient reportedly had a locked knee, pain and was limping.After approximately 7 hours the patient reportedly developed shaking, chills and tremors.A 103-degree fever was also reported, in addition to nausea and back pain.After 24 hours, the patient reportedly had a 101-degree fever.Additional information was not provided.The current status of the patient is unknown.The product was not available for analysis.The lot number was not provided.A review of the batch record could not be performed.Anika product is manufactured and released to applicable procedures and specifications.A three-year retrospective review of all non-conformances for monovisc between 2021-2024 was performed.There were no non-conformances documented that was related to the reported event.A three-year review of product retention reports was performed.There was no nonconformances related to the reported event in the inspection reports.A review of the stability study report for (monovisc) was performed.There was no nonconformances documented in the stability study report.The conclusion for the product stated that the product has met all required specifications and tolerances.A temporal association between the use of the monovisc device and the patient experience could not be established with the limited information available.The cause of the reported event could not be established.A supplemental report will be submitted upon receipt of new and relevant information.The reported event will continue to be monitored and trended for future analysis.

• Brand Name: MONOVISC
• Type of Device: 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: 18839638
• MDR Text Key: 336958410
• Report Number: 3007093114-2024-00003
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 690016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other