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Lot Number 8RSP006F
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Weakness (2145); Neck Stiffness (2434); Ambulation Difficulties (2544)
Event Date 02/09/2019
Event Type  Injury  
Event Description
Received first ever injection of synvisc hylan g-f 20, 2 ml in knee. Within <24 hours, all joints were extremely painful. Couldn't bend my knees to sit/stand. Many muscles grew stiff, especially neck (could not turn head) and all muscles around midriff. Felt as if i were breathing out against a "reverse" iron lung. My lungs and respiratory system were ok, but the muscles from below my bust down-front, back, and sides - were so tight, i could not breathe normally. There were 3 syringes in the box, 2 remain. On (b)(6) 2019, i had an injection of synvisc in my left knee. Synvisc is made of cocks' and hens' combs, and it is supposed to help rebuild cartilage. Before the specialty pharmacy in (b)(6) sent the injections, i spent probably an hour on the phone with one of their reps, going through a long list of things to which i had ever had an allergic reaction. Of main concern were chickens, other fowl, feathers and such. Nothing indicated that i might have an allergic reaction. By the afternoon of (b)(6) 2019, every joint and muscle in my body was aching, sort of like a universal arthritis attack on all my joints at once. It was so bad i left work early. I called the physician who had done the injection when i got home, and he said to go to the emergency room, so i went to the (b)(6) hosp er, the closest to where i live in (b)(6). My symptoms were severe pain and stiffness in all my joints and throughout my back. I could not bend my knees at all to sit down or get up from a chair. I couldn't turn my neck (which has a titanium plate) left or right at all, due to joint pain and muscle stiffness. All the muscles around a large swath of my midriff grew completely stiff and painful. I felt as if i were breathing out against an iron lung that was pressing in. However, i could tell that my lungs, bronchial tubes, and esophagus were functioning normally. It was the stiff muscles all around my midriff that were making breathing difficult. The stiffness and pain in my midriff eased up after about 48 hours. The other extreme pain lasted for about six days, and then very, very gradually began to ease as well for a few days after the "attack", i couldn't even get up or down from a chair without huge effort. I couldn't get around without a walker for the first few weeks. Even now, more than a month later, i still have pain and stiffness in my neck, shoulders, lower back, and knees. The worst pain is in my neck, right shoulder, and left knee. My lower back hurts worse in the morning, and it's hard for me even to stand. I tire very easily and have no energy. I do not feel well. I feel bad. I get exhausted doing tasks that were not tiring at all before (b)(6). My concentration is not what it usually is. I cannot sit for too long, stand for too long, or walk for too long. I also have a hard time sleeping. Sometimes it is the joint pain that keeps me from falling asleep. Sometimes, i just can't sleep. I cannot find a comfortable position for sleeping. (this is being written on (b)(6) 2019). One of four things most likely happened: i had an allergic or other weird type of reaction to the synvisc; the synvisc is thick about the consistency of honey and that could have caused a physical, rather than an allergic, reaction to the injection. (i've had a few cortisone shots in various joints over the years, and they have worked well, without any problems or complications. Of course, cortisone isn't thick, and it relieves pain); the synvisc injection may have been contaminated (there was a voluntary recall of synvisc-one in december 2017, but some of the tainted injections were never returned. My synvisc injection was from a different lot than the tainted one, but there is always the possibility that this lot may have been contaminated, too. If it happened once, it could happen again; another possibility is that the injection and the reaction are unrelated, they just happened at the same time by chance. However, since i have never had anything vaguely resembling what happened to me on (b)(6) happen before. I think this is unlikely. The only thing i can think of that wasn't on the list of things i am allergic to, and which might somehow be related to synvisc, is catgut sutures. When i had my first thyroid operation 35 years ago, the sutures were catgut, something organic that was supposed to dissolve over time. Well, the sutures didn't dissolve. They popped out of my incision one or two at a time over the course of several weeks. Not fun. I can see that the catgut might be similar in structure to the synvisc, both seem to be something that could be boiled for hours to get an aspic or gelatin. Meat aspic is not something i've seen much in the u. S, but it's popular in some other countries. I called the specialty pharmacy that sent the synvisc to my physician's office and talked to one of the pharmacist there for a long time. He said he'd never heard of a reaction like mine and didn't seem too impressed by my catgut theory. So i'm still at ground zero for reasons why, although a contaminated injection would explain a lot of my symptoms. I went to see my physician again on (b)(6). He sent me for more blood work, and i saw him again on (b)(6). He extended my medical leave until (b)(6) 2019. Meanwhile, i am doing ot and pt each twice a week and trying to get better. I see a rheumatologist on (b)(6) 2019 and am trying to find out if she wants add'l lab work before she sees me. At this point, i can usually get around my apartment without the walker, but my balance still isn't excellent, so i use it when i get tired or have to go out. I am doing some chiropractic on my back, and that has helped some. But i won't let anyone touch my neck because of the titanium plate i have had since (b)(6) 2016 (anterior cervical discectomy and fusion, 4 levels). The most serious situation is actually my neck because the muscle there are still so stiff i can't turn my head more than an inch or two to either side. I cannot drive on the freeway until that gets a lot better. Meanwhile, the other joints are slowly calming down. They are not back to normal by a long shot, but i'm hugely better than the first week after the onset of the "attack" i am also not as weak as i was at first, but i am definitely not my usual energizer bunny self who worked 10 to 12 hours days regularly (as the events and sponsorship manager for the foundation of a local non-profit hospice) with a daily commute 2. 5 to 3 hours, round trip. Now i am exhausted by doing just one thing, like pt or ot. I still do not feel well at all, and this is not like me. The tight muscles around my midriff were better within 2 days. The bad joint pain was less in six days, but some joints are still stiff and painful. My neck is still stiff, painful, and does not turn well. My right shoulder and left knee are still quite painful and stiff. I am on disability until (b)(6) 2019 at present. Doing pt and ot. Still on medical leave, currently in until (b)(6) 2019.
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Manufacturer (Section D)
MDR Report Key8452751
MDR Text Key140122311
Report NumberMW5085161
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/03/2021
Device Lot Number8RSP006F
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 03/25/2019 Patient Sequence Number: 1