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

Model Number	690-016
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device was not returned to the manufacturing plant for evaluation.Evaluation into the device manufacturing records do not show any non-conformances or trend that would show a temporal association between the device and the reported event.A supplemental report will be submitted up receipt of new and relevant information.
Event or Problem Description
Medwatch mw5098536 was forwarded to anika therapeutics by the fda.The patient reported that during a monovisc injection, the patient experienced pressure and pain.Patient continued experiencing pain weeks after the injection.The patient returned back to the physician and received an mri which showed that the patient had a stress fracture in the right knee.No additional information was provided to the manufacturer.
Additional Manufacturer Narrative
The reported event is not confirmed.The manufacturer solicited additional information.The reported device was not returned to the manufacturing plant for evaluation.The lot number was not provided.Evaluation into the device records do not show any previously reported events or trend that would show a temporal association between the device and the reported event.The manufacturer will track and monitor the reported event.A supplemental report will be submitted up receipt of new and relevant information.
Event or Problem Description
See h10 for additional information.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 11680464
• Report Number: 3007093114-2021-00007
• Device Sequence Number: 19604162
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention