MAUDE Adverse Event Report: UNKNOWN MONOVISC (LEFT KNEE); ACID, HYALURONIC, INTRAARTICULAR

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 07/11/2023

Event Type  Injury  

Event Description

Reporter called and said that she received monovisc injections in her right knee and left knee two weeks ago.Two weeks post-injection, both of her knees are now worse with swelling, pain when standing and walking, and considerable loss of range of motion.She is not able to find any relief from the pain.Reference report: mw5120191.

• Brand Name: MONOVISC (LEFT KNEE)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17408137
• MDR Text Key: 320077904
• Report Number: MW5120192
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female