MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE PFS; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 04/01/2019

Event Type  Injury  

Event Description

Received spontaneous call from patient reporting that the durolane is not working and she is in constant pain, which is affecting her quality of life.Patient states that synvisc worked perfectly and she will like to go back to synvisc.No other information known.Reported to (b)(6) by: patient/caregiver.

• Brand Name: DUROLANE PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 8735532
• MDR Text Key: 149388279
• Report Number: MW5087634
• 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: Physician
• Type of Report: Initial
• Report Date: 06/11/2019

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2019
• Patient Sequence Number: 1
• Patient Age: 80 YR