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

Model Number	690-016
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injection Site Reaction (4562)
Date of Event	12/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon conclusion of the manufacturing investigation.
Event or Problem Description
On 17may21, anika received an fda report mw5098536 with the following information: during injection of monovisc, intense pressure and severe pain and upon immediate completion of injection, syncopal event and continued severe pain for weeks and still occurring.When returned to doctor with severe pain, received mri with results of medial femoral condyle stress fracture to same right knee.
Additional Manufacturer Narrative
A manufacturing plant investigation was not performed due to the product not being returned and the lot number was not provided.This symptom will continue to be monitored and trended.A supplemental report will be submitted upon receipt of new and relevant information.
Event or Problem Description
See h10 for plant investigation.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC.; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 11962895
• Report Number: 3007093114-2021-00072
• Device Sequence Number: 4403838
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P090031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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 Model Number: 690-016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5098536
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention