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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE GEL INJECTION; ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC ONE GEL INJECTION; ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Sweating (2444); Shaking/Tremors (2515)
Event Date 08/31/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, dr (b)(6) of (b)(6), gave me synvisc one gel injections in my left and right knees.It was the first shot for my left knee and the second time for my right knee.A synvisc one shot several years ago in my right knee helped my arthritis pain so much that i desired to have another injection, this time in both knees.I have been diagnosed with osteo and rheumatoid arthritis, as well as fibromyalgia.There was no problem at all with the initial injection to the left knee.(adverse reactions are rare with first-time shots; likelihood increases as shots increase.) to my great horror, however, i had the worst pain i ever experienced with the right knee injection, which was the second shot for my right knee.It was hard for me to believe such severe pain could come from a knee injection.Although i have suffered chronic pain from fibromyalgia and arthritis for years, this time the pain was literally off the charts.It required two weeks' hospitalization in a pain trauma unit to subside and several weeks of therapy to regain the use of my right leg.More than two months later, i still have quite a bit of knee pain and can only stand or walk five minutes without resting.Case details: after the injections, it took a day or so before the lidocaine wore off.Over the labor day weekend, i began to experience pain radiating from the right knee injection site to my hip.It felt like it was traveling up the sciatic nerve.Then it eventually radiated back down the inside of my leg to my knee.On a scale of 1 to 10, i would rate this pain as a 20.The only visible symptoms were my right knee swelled up four inches larger than my left knee and i could no longer stand or walk.On (b)(6), the pain became so severe that my husband called an ambulance around 2 a.M.And took me to (b)(6) campus.I had a horrible emergency room experience.I personally believe that the doctor (like me initially) had a hard time believing that much pain could come from a mere knee injection.Perhaps she thought i was faking it or seeking narcotics.At any rate, i was left to writhe in pain for an hour without relief.When my normally low blood pressure shot up to over 200, and i was shaking and drenched in sweat it dawned on medical staff that perhaps my pain was real.Finally i was given dilaudid and morphine.By then, my pain ramped up to an unmanageable level.From my reading, i truly believe this was some rare sort of hyperalgesia state secondary to severe fibromyalgia, which i have been suffering from for years.When i refused to leave because of continuing severe pain, i was admitted to the hospital.I continued to receive minimal pain meds while at the (b)(6) campus and was given physical therapy, which only added insult to injury.After a few days of this, i gave the (b)(6) campus an ultimatum: either treat my pain effectively or put me in some sort of semi-conscious state, because i literally could not stand one more day of that kind of pain.I was simply amazed to see how poorly equipped the monroe campus was to handle severe pain.On (b)(6) i was transferred to (b)(6) main campus in (b)(6) by ambulance.My bp was so high the ambulance crew hesitated to take me in.I was put in the 9th floor trauma unit and seen by the acute pain management team.I am especially indebted forever to (b)(6), a nurse practitioner.She is the first person that i felt really listened to me.Finally i received adequate pain relief, being put on an iv ketamine drip, iv dilaudid every four hours, plus oxycodone, a lidocaine patch on my knee, a fentanyl patch on my shoulder, and maximum doses of tylenol around the clock.In ten days the pain gradually subsided.My case was mismanaged from the very beginning due to the arrogance of dr (b)(6), the orthopedic doctor who administered the knee injection.He was naturally the first doctor i asked for, and he insisted that such a reaction to the synvisic one shot was (in his exact words) "impossible." it was obvious to me that he was more interested in protecting himself than his patient.I asked if he may have inadvertently hit a nerve or something; he informed me there are no nerves there.When asked about synvisc one recalls (yes, there have been more than one) or the possibility of pseudoseptic arthritis, he was annoyed.Dr (b)(6) refused to acknowledge my pain or consider the possibility of an adverse reaction to the knee injection, even though i later learned that medical literature reports dozens of such adverse reactions.He signed off my case and "dumped" me on the neurology team, who compassionately provided much-needed pain relief.I am not interested in suing dr (b)(6).I know that i am the one who innocently asked for this injection.I also understand that unexpected, even tragic, events occur in medicine.However, i was done great disservice by dr (b)(4)'s failure to treat my pain and his denial that there was even remote possibility of an adverse reaction.My pain kept getting worse and dr (b)(6) took turns ignoring or denying it, which made me livid.The neurologist ordered ct scans and mris, which revealed a herniated disc in my mid-back.I was given an epidural steroid injection, which did absolutely nothing for the pain in my knee.One neurologist, dr (b)(6), agreed that he also thought the pain was a result of the shot in my knee.A second neurologist, dr (b)(6), said he could fix my back, but it would not help my knee.I was in two hospitals from (b)(6) thru (b)(6).I have have since weaned myself off oxycodone, muscle relaxants, and gabapentin.Although my pain is better, it had by no means disappeared.I had to take maximum doses of tylenol and advil around the clock for weeks.I used a tens unit, as well as heat and cold therapy.I completed several weeks of physical therapy and can now walk without a walker.Two weeks lying flat on my back in bed severely weakened me.I am nowhere near my former level of activity, which was not all the great to begin with due to rheumatoid arthritis and fibromyalgia.My husband took two weeks off from work to stay by my side 24/7 because i was in such severe pain.I am starting to get my hospital bills dribbling in now, the first one was for over $(b)(6).Thankfully i have health insurance, but i am sure we will be responsible for thousands when this is all said and done.To add insult to injury, i paid over $(b)(6) out of pocket for the privilege of being tortured by synvisc one.I know you cannot change what has happened to me.But at the very least, can you please help doctors understand the need to listen to patients? once i finally fit into the right "hole" at (b)(6), everything ran like a well-oiled machine.I can't say enough good things about your compassionate and competent nurses and other staff.The new facilities are state of the art and beautiful.I did not meet a single nurse or aide whom i would rate less than a+.I only wish i could say the same about the doctors.The vast majority of them were wonderful, but it only takes one negative experience like this to impact me for life.I am telling you these things because i refuse to take any responsibility for allowing this to happen to any other unsuspecting person.Orthopedic doctors can and should exercise due diligence and inform patients of the possible side effects of knee gel injections.I do know that adverse reactions cannot be reliably predicted, but they can indeed be treated compassionately and effectively.Ignoring and denying the problem will do no one any good.I am confident you will take this in the spirit in which it was intended.I am a loyal (b)(6)'s patient and will continue to be.I will never forget the excellent treatment and compassionate care i received when the doctors finally believed i was in agony and started to treat my pain.I just cannot understand why i had to suffer for days before this ever happened, sincerely, (b)(6).Dr (b)(6) orthopedic surgeon.
 
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Brand Name
SYNVISC ONE GEL INJECTION
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key8089695
MDR Text Key128251417
Report NumberMW5081470
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 11/06/2018
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 No Information
Device Expiration Date08/21/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/19/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age60 YR
Patient Weight127
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