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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 04/01/2020

Event Type  Injury  

Event Description

I had received orthovisc in my left knee for arthritis.After receiving the injections i started to experience severe pain and was unable to bend or straighten my knee without helping with my arms.They were locking and clicking.Neither ice nor heat had helped.I went back to the orthopedic and they basically blew me off saying that i can try another cortisone shot in a month.After doing research, i found a lot of the same complaints on the reviews online.Apparently people don't know they can and should report it to you.Fda safety report id# (b)(4).

• Brand Name: ORTHOVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 10004965
• MDR Text Key: 189446743
• Report Number: MW5094285
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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; Disability
• Patient Age: 50 YR
• Patient Weight: 107