MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Device Problem Insufficient Information (3190)

Patient Problems Fainting (1847); Headache (1880); Hyperglycemia (1905); Memory Loss/Impairment (1958); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Chills (2191); Cramp(s) (2193); Sweating (2444)

Event Date 02/14/2014

Event Type  Injury  

Event Description

This unsolicited device case from united states was rec'd on (b)(4) 2014 and add'l info was rec'd on (b)(4) 2014 (both info processed together) from a consumer.This case is cross reference to cases (b)(4) (same pt).This case concerns a (b)(6) female pt who had feeling faint/ having to put her head down, nausea/queasy, tiring quickly/ feeling weak, legs didn't work, cold sweat, still using a walker, pain from knee to the ankle on inside along bone and towards back side, injection site hurts to touch, tiring quickly/ feeling weak, knee pain, upset stomach, leg cramps/ spasms, headache, chills, bad memory and blood sugar increased after receiving treatment with synvisc-one.The pt's past drugs included synvisc-one.Relevant past medical history included nausea, weak, fever, chills, passed out, threw up all with third shot given in 2012, not able to walk, swelling around knee, left leg pain, difficulty walking, hard to walk all with second shot given in 2011 and discomfort with first shot given in 2011.Relevant concomitant medication includes metformin hydrochloride (metformin) for diabetes.It was also reported that the pt was allergic to sulfa drugs.On (b)(6) 2014, the pt rec'd treatment with synvisc one injection (route of administration, dosage regimen, frequency, lot/batch number and expiration date unk) into each knee for knee osteoarthritis (lack of knee cartilage, knee pain).The pt said, she had same reactions as with the previous three injections which lasted for at least a yr, except she didn't pass out.The same day by night, pt complained of stiffening up, was using walker by bedtime, at 5:00 am, pt complained of nausea/queasy, feeling faint/having to put her head down, but not passing out, cold sweats, very week, her legs didn't work and sugar levels were 185 (average 115).Following her fourth injection, pt complained of bad memory and she could not even remember that her son was going to have a baby.On (b)(6) 2014, pt slept most of the time and could not move.On (b)(6) 2014, pt felt queasy and had headache and chills.On (b)(6) 2014, pt was feeling better but complained of pain around knees; still can't stand w/o walker and had leg cramps/spasms.On (b)(6) 2014, pt was able to take few steps but was having leg cramps.On (b)(6) 2014, the pt was feeling much better with cramps and spasm in legs during night.The pt was walking with walker and a few steps w/o walker.The legs were tight around knees.Around 6:00 pm, the pt was feeling better and had a complained of pain from knee to the ankle on inside along bone and towards back side.Corrective treatment: ibuprofen ((b)(4)) and paracetamol ((b)(4)) for injection site hurts to touch, pain from knee to the ankle on inside along bone and towards back side, knee pain and headache.Outcome: not recovered/ not resolved for the events of legs didn't work, still using a walker, pain from knee to the ankle on inside along bone and towards back side, leg cramps/spasms, knee pain, tiring quickly/ feeling weak and blood sugar increased.Unk for the events of feeling faint/ having to put her head down, nausea/queasy, cold sweat, headache, chills, upset stomach and bad memory.Recovering /resolving for the event of injection site hurts to touch.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) and results were pending for the same.Seriousness criteria: important medical event for feeling faint/ having to put her head down.No further info was provided.

Manufacturer Narrative

Pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: in this case, the causal role of the suspect drug synvisc one cannot be excluded for the occurrence of the event of feeling faint/ having to put her head down (presyncope), however the lake of info regarding the underlying medical history and the concomitant medications used by the pt precludes the complete case assessment.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: 55 corporate drive; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089816698
• MDR Report Key: 3682682
• MDR Text Key: 20697179
• Report Number: 2246315-2014-26078
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 02/24/2014

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNVISC ONE (PREV.), DATE OF TX: 2011 - 2012; METFORMIN (CON.); SULFONAMIDES (PREV.)
• Patient Outcome(s): Other
• Patient Age: 68 YR