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

Model Number SYNOJOYNT 1% SODIUM HYALURONATE, 3 DOSE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 08/17/2023

Event Type  Injury  

Event Description

On 8/24/2023, it was reported by a facility representative via phone that a patient experienced an allergic reaction to an 82197-0721-16 synojoynt injection.After the injection, the patient started to experience a headache within an hour.The patient also experienced body aches, soreness, and a tinkling feeling from the knee up the body.The injection was administered in the office on (b)(6) 2023; the patient was awake and not under anesthesia.The patient's knees appear normal, with no signs of redness, inflammation, infection, or discharge.The patient does not have any known allergies.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: SYNOJOYNT 1% SODIUM HYALURONATE, 3 DOSE
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 17775328
• MDR Text Key: 323752713
• Report Number: 1220246-2023-07950
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/19/2023

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
• Device Operator: Health Professional
• Device Model Number: SYNOJOYNT 1% SODIUM HYALURONATE, 3 DOSE
• Device Catalogue Number: 82197-0721-16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/19/2023
• 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): Other