MAUDE Adverse Event Report: ARTHREX, INC. SYNOJOYNT 1% SODIUM HYALURONATE, 3 DOSE; HYALURONIC ACID

Model Number	SYNOJOYNT 1% SODIUM HYALURONATE, 3 DOSE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 9/13/2022, it was reported by a patient via phone that she had a side effect after having received a second synojoynt 1% sodium hyaluronate knee injection on (b)(6) 2022.Her first knee injection procedure on (b)(6) 2022 went fine, and she had no issues or side effects.On (b)(6) 2022, after the second knee injection procedure, she developed that night a uti which was according to her doctor a known side effect.Her third injection is scheduled for (b)(6) 2022, but she is hesitant to continue with the treatment and will seek medical advice from her obygn practitioner first.No action was requested, she just wanted to report the complaint.
Additional Manufacturer Narrative
See attached vendor evaluation.

• Brand Name: SYNOJOYNT 1% SODIUM HYALURONATE, 3 DOSE
• Common Device Name: HYALURONIC ACID
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20438886
• Report Number: 1220246-2024-08114
• Device Sequence Number: 8497217
• Product Code: MOZ
• UDI-Device Identifier: 00888867413689
• UDI-Public: 00888867413689
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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: SYNOJOYNT 1% SODIUM HYALURONATE, 3 DOSE
• Device Catalogue Number: 82197-0721-16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown