MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Syncope/Fainting (4411)

Event Date 12/04/2020

Event Type  Injury  

Event Description

During injection of monovisc, intense pressure and severe pain and upon immediate completion of injection, syncopal event and continued severe pain for weeks and still occurring.When returned to doctor with severe pain, received mri with results of medial femoral condyle stress fracture to same right knee.

• Brand Name: MONOVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 11076368
• MDR Text Key: 224044280
• Report Number: MW5098536
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 61