MAUDE Adverse Event Report: GENZYME BIOSURGERY SYNVISC ONE (HYLAN G-F 20), 2 ML (16 MG); INTRA-ARTICULAR HYALURONIC ACID

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Inflammation (1932); Pain (1994); Joint Swelling (2356); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 07/14/2014

Event Type  Injury  

Event Description

On (b)(6) 2014: dr.(b)(6) (my rheumatologist) injected synvisc-one bilaterally into my knees (third time).Within two hours after the injection i experienced the following reaction: severe knee pain, knee stiffness, knee swelling, knee warmth, ankle swelling, extreme difficulty in walking, essentially, loss of all my self functioning around my house (my wife had to help me with everything).Also, charoot foot (b)(6) 2014.On (b)(6) 2014: dr.(b)(6) ordered lab tests (c-reactive protein + comprehensive metabolic panel + sedimentation rate), which confirmed the clinical that i had severe inflammation.From (b)(6) 2014: i self-medicated with ice packs to both sides, and ibuprofen 400 mg/d, and lasik (furosemide) 20 mg ((b)(6)), to reduce inflammation and edema.Note: the symptoms of the synvisc reaction subsided in about one week on my left side, but not on my right side (symptoms now consisting of mostly swelling, redness and increased warmth of the right foot and ankle).On (b)(6) 2014: i saw dr.(b)(6) (my podiatrist); she immediately diagnosed me with charcot foot, and she placed a removable "boot" on my right foot.And, she instructed me not to walk on my right foot (i.E., completely non-weight bearing)until the condition resolves.On (b)(6) 2014: x-ray of my right foot (= no fractures).On (b)(6) 2014: saw dr.(b)(6) for a follow-up: right foot not healed; continue with 'boot'.On (b)(6) 2014: x-ray right foot (= fallen arches/flatfoot; no fractures).On (b)(6) 2014: i saw dr.(b)(6) for follow-up: right foot not healed; continue with 'boot'.On (b)(6) 2015: dr.(b)(6) found no more signs of charcot arthropathy; 'boot' removed.Dose or amount: 2 ml (16 mg).Frequency: 4th time.Route: intra-articular.Dates of use: (b)(6) 2001 + (b)(6) 2012+ (b)(6) 2014.Diagnosis or reason for use: osteoarthritis (of knees).

• Brand Name: SYNVISC ONE (HYLAN G-F 20), 2 ML (16 MG)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY; ridgeside NJ
• MDR Report Key: 5053485
• MDR Text Key: 25051321
• Report Number: MW5055887
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 102