MAUDE Adverse Event Report: GENETECH SYNVISC ONE; ACID, HYALURONIC INTRAARTICULAR

Model Number SYNVISC ONE

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Inflammation (1932); Pain (1994); Swelling (2091); Arthralgia (2355); Reaction (2414); Ambulation Difficulties (2544)

Event Date 11/15/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, i received synvisc one injection from my rheumatologist in my right knee and left knee due to diagnosis and treatment for osteoarthritis.On (b)(6) 2017 in the morning symptoms noted included: very substantial swelling and very significant pain in knees and legs, difficulty walking, marked joint stiffness, difficulty walking up stairs, difficulty getting in and out of car, and incredible fatigue.Follow up appointment scheduled on (b)(6) 2017 due to concerns and both knees were drained (left knee 40 cc of fluid and right knee 20 cc of fluid).Rheumatologist sent samples from both knees for lab testing to rule out infection.Rheumatologist prescribed 15 days of oral steroid treatment.Lab testing results indicated no infection however synovial fluid was hazy with a 16,500 units/ liter cell corresponding with inflammation and adverse reactions from synvisc one injection.Symptoms continued for 10 days and i followed up with rheumatologist on (b)(6) 2017 and my right knees were drained with 40 cc of fluid.As of (b)(6) 2017 symptoms are continued and of significant concern.On (b)(6) 2017 i was notified by my rheumatologist, dr.(b)(6), arthritis institute of michigan, on (b)(6) 2017 he received notification from the manufacturer of synvisc one, genzyme/ sanofit, there was a stop use notice issued for the lot number, 7rsl021, of the injection i received.I was informed to contact the manufacturer sanofi/genetech at (b)(6), to report my adverse reaction.I contacted sanofi/genetech on (b)(6) 2017 and informed them of the adverse reaction symptoms i experienced as described above.I also inquired about additional information and questions about the stop use notice and i was informed this was a product hold and was currently being investigated by sanofi and the fda regarding lot number 7rsl021.The manufacturer informed me at this time no product recall has been issued while the investigation is being conducted.The manufacturer informed me any additional information would be provided to my health care provider to provide for me.Following the results of the tab test dr.Dowd informed me there was no joint infection.However the fluid was hazy and the synovial fluid white blood cell count was in the high range 16,700 indicating an adverse reaction and inflammation.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): GENETECH
• MDR Report Key: 7100872
• MDR Text Key: 94408849
• Report Number: MW5073843
• 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: Other
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYNVISC ONE
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 110