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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME GENZYME - SYNVISC

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GENZYME GENZYME - SYNVISC Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Collapse (2416); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)
Event Date 06/28/2017
Event Type  Injury  
Event Description
On 2013: first series of 3 injections of synvisc lt knee.Following each injection, 2 weeks apart, there was no increase in pain.Two weeks apart, there was no increase in pain.Two weeks after the 3rd injection (6 weeks after the series began) my left knee was pain free for 6-8 months.On 2014: second series of 3 injections.This time the doctor used euflexxa - lt knee.I had no increase in pain following each injection, however the pain in my lt knee never decreased.On 2015: third series of 3 injections of synvisc lt knee.Following the 2nd injection of synvisc, a week or 10 days apart, i had no pain in my lt knee.The 3rd injection was followed by 2-3 weeks of pain, slightly worse than when i started this series of lt knee injections.Following the 3rd injection, after 2-3 weeks, i was pain free for 6-8 months.On 2016: fourth series of 3 injections of euflexxa lt knee.The doctor was retiring, i received the third injection on his last day.Because of the cost of synvisc, the doctor's office no longer carried it.I would have had to go through my drug company (caremark) and that could not have been accomplished before the doctor retired.That is why i consented to try euflexxa again.I had no increased pain following each injection and i had no decrease in lt knee pain for a second time with euflexxa.This was (b)(6) 2016.(b)(6) 2016: i went to a rheumatologist.(previous injections were administered by an orthopedist.) the rheumatologist said she could provide the single injection synvisc but i would need to wait until (b)(6) for (b)(6) to cover the drug and the administration.On (b)(6) 2016 i received a single injection synvisc in my knees, bilaterally.The pa used lidocaine and cortisone with each injection.She was hesitant to do both knees at the same time but i wanted relief of my pain (now in both knees) and i believed the pain i endured after the second series of synvisc was well worth enduring, to be pain free for a minimum of 6 months.My knees felt "funny" for 2 hours, there was little increase in pain for a few days and then back to the same old pain that i had now had for years.On 2017, i went back to the orthopedic practice.The new (to me) doctor said he'd be happy to administer synvisc but i had to get caremark to send it to him and to have (b)(6) pay for the injection.I had to wait until after (b)(6).(my copay for the 2nd series was (b)(6) dollars - now, in 2017, it was (b)(6) dollars.I still have the same insurance.I'm not sure why i even mentioned cost except that it is time for a generic to come on the market.) on (b)(6) 2017 1st injection of this series of synvisc.Increased pain began a few hours later and lasted until (b)(6) 2017.On (b)(6) 2017 2nd injection of this series of synvisc.Increased pain began a few hours later and lasted until (b)(6) 2017.On (b)(6) 2017 final injection of this series of synvisc.Pain began a few hours later and it was greatly increased from my usual lt knee pain.(i only had the lt knee injected.) by 5 pm (injection at 9 am), i was having a hard time bearing any weight on my left leg.At 7 pm, i had chills and went to bed.The chills subsided in a little over an hour.About 10:30 pm, my husband attempted to help me to the bathroom.I could bear no weight on my left leg and it was excruciatingly painful to move my left leg even the slightest bit.After about 5 steps, i started to perspire and i felt very very hot in my core - not to the touch.It was at that point that i collapsed on the floor.I do not believe i passed out.I heard my husband say, "don't hit your head on the floor" (ceramic tile) and i believe i collapsed slow enough that he was able to step around me and hold my head off the floor.While laying on the floor i was getting a feeling of being extremely hot.I asked for cold wet towels to attempt to feel cooler.After 5 or 6 cold towels on my neck and face i felt better and tried every which way to get to my feet.Every little movement caused unbelievable pain.Finally, after about 20 minutes, with the garden kneeler handles, i was able to boost myself to my rt knee and after that to a standing position on my rt leg.Getting on and off the commode was excruciating.I have never in my lifetime had this amount of pain.The following day, i stayed in bed, not eating or drinking anything until 5 pm.The next morning i called the doctor's office, explained the amount of pain and was told to take motrin.When i said my internist told me, at (b)(6) years of age, to not take any nsaid except aspirin, the assistant said to take aspirin then.I tried aspirin, it helped very little.I wanted relief of my pain, that i had now had for over 48 hours, so i took motrin because i know it works better than aspirin for pain and swelling.The only thing i had done prior to that was to use ice off and on.It took about a week for the pain to decrease significantly, so i could bear my full weight on my left leg.Today is (b)(6) 2017, over 4 weeks since the 3rd injection in the series of synvisc.My lt knee is still bigger than my rt knee, but not a great deal bigger.My left knee still is painful, especially at night, and off and on during the day.So far, the pain has not been resolved as it did with my 1st and 2nd series of synvisc injections.My retired orthopedist once said i could have a reaction to synvisc.I asked what the reaction was? he said, pain.I had the 2nd series anyhow because euflexxa didn't do a thing for the pain.It was the 3rd series of injections of synvisc that caused overwhelming pain.
 
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Brand Name
GENZYME - SYNVISC
Type of Device
GENZYME - SYNVISC
Manufacturer (Section D)
GENZYME
MDR Report Key6787619
MDR Text Key82665715
Report NumberMW5071519
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier58468009001
UDI-Public58468-0090-01
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date12/01/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age77 YR
Patient Weight100
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