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

Device Problem Lack of Effect (4065)

Patient Problem Pain (1994)

Event Date 11/14/2022

Event Type  Injury  

Event Description

On 08feb2023 it was reported to anika that a patient of unknown age and demographic reported experiencing pain after receiving a full dose of monovisc in both knees.The patient reported that the pain started immediately after the injection and spread into the thigh and calf in the following day.The patient reported being prescribed steroids and pain medication to treat the patient pain.The prescribed medications are: famotidine 20 mg tablet, methylprednisolone 4 mg dosepk, nabumetone 500 mg tablet.The patient reported still experiencing the pain when additional information was solicited.The patient's comorbidities is unknown.There was no report of any malfunction or unusual appearance with the device at the time of use.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 by the manufacturing plant.

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.Supplemental report: the reported event could not be confirmed.It was reported to anika by the patient who received monovisc injection on november 14th and experienced pain daily in the thighs, knees, and calves.The patient was prescribed a 7-day steriod and a 30-day pain reliever that did not work at all.Additional information was provided upon request, the pain started immediately and continued to spread as the days passed by, the patient had full dosage in both knees , patient's medication included famotidine 20 mg tablet, methylprednisolone 4 mg dosepk, nabumetone 500 mg tablet.The current status of the patient is unknown.There was no report of any unusual appearance with the packaging or device at the time of use.There was no malfunction reported at the time of use of the device.There was no delay in the procedure.The device was not returned to the manufacturing plant for evaluation.The part number and lot number was not provided.A batch record review could not be performed.All product manufactured by anika and anika entities are released to applicable procedures and specifications.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.

Event Description

On 08feb2023, it was reported to anika that a patient of unknown age and demographic reported experiencing pain after receiving a full dose of monovisc in both knees.The patient reported that the pain started immediately after the injection and spread into the thigh and calf in the following day.The patient reported being prescribed steroids and pain medication to treat the patient pain.The prescribed medications are: famotidine 20 mg tablet, methylprednisolone 4 mg dosepk, nabumetone 500 mg tablet.The patient reported still experiencing the pain when additional information was solicited.The patient's comorbidities is uknown.There was no report of any malfunction or unusual appearance with the device at the time of use.Additional information was solicited.

• 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: 16468380
• MDR Text Key: 310522323
• Report Number: 3007093114-2023-00008
• 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: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization