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 Problem Local Reaction (2035)

Event Date 12/12/2023

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 18january2024 the distributor reported that a (b)(6) year old male patient received a full dose monovisc injection without guidance on or about (b)(6) 2023.Patient comorbidities is arrhythmia, dementia, gastric reflux, hypertension, and neuropathy.Patient protocols was rest, ice packs, tylenol and ace bandaging.The patient received arthroscopic irrigation and debridement on (b)(6) 2023.The patient reportedly experienced inflammation.It was indicated that the patient may have had an infection however it was later reported that there was no aerobic or anerobic growth isolated.It was reported that the patient's condition improved after the last visit on (b)(6) 2024.

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.Supplemental report: the reported event is not confirmed.Additional information was received indicating that the patient had inflammation and infection was indicated but there was no aerobic or anaerobic growth isolated.The patient received a full dose of monovisc.There was no guidance used when delivering the contents of the monovisc syringe.The patient was treated with tylenol, ice packs and an ace bandage application.Medical records were not provided upon request.The current status of the patient is unknown.A review of the batch record could not be performed due to the lot number not being provided.All product manufactured by anika and anika entities are released to applicable procedures and specifications.A three-year retrospective review of all non-conformances for monovisc between 2021-2024.There were no non-conformances documented that was related to the reported event.All retention inspection reports dating back to 3 years prior to the date of awareness ((b)(6) 2024) were reviewed.There was no nonconformances related to the reported event documented in the retention 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.The cause of the reported event could not be established.The reported event will continue to be monitored and trended for future analysis.

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 (b)(6) 2024 the distributor reported that a 89 year old male patient received a full dose monovisc injection without guidance on or about (b)(6) 2023.Patient comorbidities is arrhythmia, dementia, gastric reflux, hypertension, and neuropathy.Patient protocols was rest, ice packs, tylenol and ace bandaging.The patient received arthroscopic irrigation and debridement on (b)(6)2023.The patient reportedly experienced inflammation.It was indicated that the patient may have had an infection however it was later reported that there was no aerobic or anerobic growth isolated.It was reported that the patient's condition improved after the last visit on (b)(6) 2024.

• Brand Name: MONOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 18703025
• MDR Text Key: 335358658
• Report Number: 3007093114-2024-00002
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 690016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 73 KG