MAUDE Adverse Event Report: SANOFI / GENZYME CORPORATION SYNVISC 1; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 12/06/2021

Event Type  Injury  

Event Description

Within 24 hours of the synvisc i injection, on (b)(6) 2021, i was unable to independently walk, drive or navigate my home.I experienced extreme and significant swelling of the knee, debilitating pain and tremendous fear that the condition i wanted to correct was made far worse.Despite intensive icing, four days after the injection, i was prescribed prednisone, which i had no effect.Day six of the injection and after three days of prednisone (sunday), my husband took me to the emergency pain clinic operated by the orthopedic practice.I was examined, the dosage of prednisone increased, and i was fitted with a brace.Thursday, (b)(6) 2021, my treating physician, withdrew fluid from the knee along with synvisc for analysis and indicated i had an extremely rare reaction to the synvisc.Today, (b)(6) 2021, i still have great pain and simply seek a return to my pre-injection status, mild but tolerable knee discomfort.With synvisc i expected some discomfort - but no disability.

• Brand Name: SYNVISC 1
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SANOFI / GENZYME CORPORATION
• MDR Report Key: 13059906
• MDR Text Key: 282640351
• Report Number: MW5106202
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: NSAID'S AS NEEDED
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: Black Or African American