MAUDE Adverse Event Report: DEPUY SYNTHES / ANIKA THERAPEUTICS, INC. MONOVISC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Local Reaction (2035); Swelling (2091); Numbness (2415)

Event Date 11/02/2017

Event Type  Injury  

Event Description

My left knee was in pain and extremely swollen and numb when touching the area.Wake up during the night in pain.Received an injection from the dr, was ok for about 2 weeks then my knee got big (swelling) pain and numbness.I still have pain, some swelling and numbness.There is also pain if you apply a little pressure by touch.Frequency: 1 x only, injection by dr in the office setting.Dates of use: (b)(6) 2017.Reason for use: dr stated, would help knee movement, relieve the pain.Leg numbness by knee (as of today (b)(6) 2018 - still have numbness.).

• Brand Name: MONOVISC
• Type of Device: MONOVISC
• Manufacturer (Section D): DEPUY SYNTHES / ANIKA THERAPEUTICS, INC.
• MDR Report Key: 7832194
• MDR Text Key: 118952973
• Report Number: MW5079478
• 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: 08/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• 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 Age: 67 YR
• Patient Weight: 90