MAUDE Adverse Event Report: BIOVENTUS GELSYN-3 PFS; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

Indication for gelsyn: unilateral primary osteoarthritis, left knee.Patient reported unplanned hospitalization for one day on (b)(6) 2021, to strengthen the bones on 2 of her toes on her left leg.One of the toes had a pin and got infected a month after surgery, and she had pain because of the infection.Pt had had flare up of symptoms and the medication not helping the symptoms.Reported to (b)(6) by pt/caregiver.

Event Description

Indication for gelsyn: unilateral primary osteoarthritis, left knee.Patient reported unplanned hospitalization for one day on (b)(6) 2021, to strengthen the bones on 2 of her toes on her left leg.One of the toes had a pin and got infected a month after surgery, and she had pain because of the infection.Pt had had flare up of symptoms and the medication not helping the symptoms.Reported to (b)(6) by pt/caregiver.

• Brand Name: GELSYN-3 PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS
• MDR Report Key: 13543816
• MDR Text Key: 285771221
• Report Number: MW5107508
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female