MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC 3 HYALURONIC INJECTIONS TO KNEE; ACID, HYALURONIC, INTRAARTICULAR

Patient Problems Loss of Range of Motion (2032); Local Reaction (2035); Ambulation Difficulties (2544)

Event Date 05/23/2023

Event Type  Injury  

Event Description

After i received the third of three shots of synvisc hyaluronic injection into my left knee, on (b)(6) 2023, a few days later and until now, over 2 months, i get excruciating pain radiating from a red swollen hurtful back of stiff left knee, pain passing down from the back of my left knee, down my calf to my ankle, making it difficult for me to walk, painful to sit, as i have to bend back of my knee, painful getting into my suv, sitting and lifting up from the toilet etc.Sitting at home taking pain meds and constantly using a heating pad on my knee to elevate the pain.Went back to my quite a few times, (b)(6), after a while took steroid pills which have not helped at all, together with ibuprofen and advil daily.Dr (b)(6) suggested a cortisone shot on (b)(6), 2023 (going next week on (b)(6), 2023) to another orthopedic knee doctor to get a second opinion as to adding more cortisone to my knee, of which i am sceptic, and to discuss on further treatment to stop this deliberating pain.The left knee was my good knee as i had a bad reaction in 2008 from a minuscus tear gone bad to my right knee, which caused me to limp, so i hoped to lubricate my good left knee to keep it functioning properly and did not expect this reaction nor did the doctor check to see if synvisc caused adverse results as i discovered too late on the net.As presently i cannot walk more that five minutes without the help of a walking stick or wheel chair.Don't know how to proceed to get back to the left leg i knew.No details of product info received, as it was mailed directly from optum rx to my doctors office.Do not know if these shots required refrigeration or what! the doctor should have read detail about this product before prescribing 3 synvisc shots.Reference reports mw5144848, mw5144849.

• Brand Name: SYNVISC 3 HYALURONIC INJECTIONS TO KNEE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 17603110
• MDR Text Key: 321961266
• Report Number: MW5144847
• 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: 08/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• 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: ADVIL ; AMLODIPINE ; IBUPROFEN 800 MG
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White