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Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Injury (2348); Arthralgia (2355); Joint Swelling (2356); Numbness (2415); No Code Available (3191)
Event Date 11/18/2017
Event Type  Injury  
Event Description
This case was cross referenced with cases: (b)(4) (cluster). This unsolicited case from united states was received on (b)(6) 2018 from patient this case concerns a (b)(6) male patient who received treatment with synvisc one and after 1 day had 2 dvts, shooting pain from the knee down/ shooting pain in my ankle, calf was like a hard charley horse, couldn't feel anything all the way to the foot, right knee swelling; after unknown latency left leg was feeling crazy, blood pressure was up, foot was swollen. Also, device malfunction was identified for the reported lot number. No concurrent conditions were reported. Patient has been taking synvisc-one for 3 years. Patient wife has been getting synvisc-one for 5 years. We were used to having some swelling and discomfort when you first get it but we did not typically have a lot of issues. On (b)(6) 2017, prior getting the synvisc-one injection, everything was normal. Patient had an appointment with the doctor for an annual physician and patient checked out ok. The doctor said that patient was good for another 100. 000 miles and laughed about that. Patient had no issues. Patient did not actually want to get the synvisc shot, but patient wife who got them every 6 months, talked patient into getting it. Patient did not typically get them until he need them. Patient was not in pain or anything but decided to get the shot. Patient had surgery and accidents before. Patient have crushed his elbow and broken bones since patient have worked in construction most my life, but this pain was different than that pain. Patient was of good health and hygiene. Patient know that he got something injected in me to numb the knee before the synvisc-one was injected. The synvisc-one was prepared in front of me while i was there in the office. Patient does not have diabetes and do not have any allergies to any bird proteins. Patient did not have any prosthetics. On (b)(6) 2017 (friday), patient received treatment with intra articular synvisc one injection once (lot number: 7rsl021; dose and expiration date: not reported) for knee pain in both knees. It was reported that the right knee was fine afterwards and patient had no problems with it. Patient did ice and heat my knee like patient always do. Patient followed the directions and did what i was supposed to like always do. The next morning ((b)(6) 2017), patient right knee was fine and had minute swelling, but not much (latency: 1 day). The left leg was very different. Patient had shooting pain from the knee down. It was terrible pain. Patient could not stand it. That saturday afternoon on (b)(6) 2017, patient went to the er (emergency room). Patient just could not stand the pain anymore. They did 'this and that' and patient had a scan and they found 2 clots, that they called 2 dvts (deep vein thrombosis). Patient calf was like a hard charley horse and patient could not feel anything all the way to the foot. Patient got medicine to calm the clot and pain down and that helped some. On (b)(6) 2017, the pain came back with revenge. The medicine wore off. The pain pills they patient was given did not work. In the er, they gave patient a drip of something that lasted a long time for the pain and the clots. On (b)(6) 2017, patient was ok. Patient know that he was floating on sunday like my feet were not touching the ground. It was like i was in la la land while patient was on those pain meds. On (b)(6) 2017, the medications wore off and the pain started again. The pain was getting worse and worse and worse. Patient was in tears at this point and almost screaming. The pain was so bad that patient could not get up out of the chair. On an unknown date in (b)(6) 2017, latency unknown, patient left leg was feeling crazy and went to the er again. Patient blood pressure was up because of all the pain that was in. It was decided to admit patient into the hospital. Patient had to go to the er on (b)(6) 2017. Patient was in the hospital from (b)(6) 2017. After patient was discharged from the hospital, patient still was in pain and for 3 weeks patient needed a roller with wheels to get around. Going to the bathroom was a project and was difficult. Patient was able to get a urinal to use from the hospital that patient could do in the bed. During this time patient was also off work and worked 32 hours a week. Patient was off of work from (b)(6) 2017 until (b)(6) 2018. Patient got all 'stoved up' being inside for so long and needed to move. Patient suffered every day. Patient was going to therapy 3 days a week. They were trying to stimulate my nerves. At this point, patient leg and calves were ok. Patient knee still hurts and foot was still bad. Patient still have no feeling in heel or ball of my feet. The feeling in the top of my foot has come back. With the bottom of my foot, if patient did not see you touch it, then patient did not know that you did. Patient was having pain like patient never have experienced before. Patient had surgery and accidents before, but this was different pain. Patient have crushed his elbow and broken bones since i have worked in construction most my life, but this pain is different than that pain. The doctor said that the clots must have blocked the nerves and caused them not to work. Some of the pain patient was feeling was like when foot falls asleep and you feel like nails on it when you try to step on it. Patient got that feeling without stepping on it at all. Patient get a shooting feeling on my foot without stepping on it. The doctor decided to put me on gabapentin 300mg at first but patient was now on 1500 mg daily. Patient was also on some kind of blood thinner and take 5 mg. Patient know that it was working because his arms and hands turn blue all the time so it was doing what it should be doing. Patient foot was just not the same. Patient go to step and since patient cannot feel the bottom of my foot, lose balance. Patient foot was swollen some too. Patient have to use a cane. Calf was like a hard charley horsewhen patient go to the therapist, they use tuning forks, do lots of poking of it to re-stimulate the nerve and they use rubber bands too. Patient was still having issues with my foot. Patient did not have shooting pain as much anymore. When patient do have it, it was typically in calf, but it goes away quickly. Recently patient had the shooting pain in my ankle and have never had that before. Patient do still have knee pain. Patient said that you could tell how old i am by how i walk. Patient left foot has always gone to the left, but now patient drag it. It was reported that knee x-rayed fine. The doctor said that patient still have space in my knee and that it was not bone on bone. They did blood work as well to determine if patient had an injection. Patient knees were not aspirated. Patient was told to ice it and do heat and the swelling in knee eventually went down. They were considering doing a nerve study with patient so that they could determine why patient have a lack of feeling, but they want to wait a little bit to see if the therapy would re-stimulate my knee. Patient don't know if he want many more needles in and a nerve study uses needles. Patient did not know if he would get another synvisc-one injection, but his wife would get it. Patient had to go to the er three times. Patient was taken by ambulance to the er one of those times. Patient had x-rays done and other scans. Corrective treatment: medicine (unspecified) for 2 dvts; gabapentin for left leg was feeling crazy; roller with wheels to get around, ice it and do heat for shooting pain from the knee down/ shooting pain in my ankle; elevate it for foot is swollen; ice it and do heat for right knee swelling; not reported for rest events outcome: unknown for 2 dvts, blood pressure was up; not recovered for rest events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: hospitalization for device malfunction, left leg was feeling crazy, blood pressure was up, shooting pain from the knee down/ shooting pain in my ankle; disability for shooting pain from the knee down/ shooting pain in my ankle; important medical event for 2 dvts pharmacovigilance comment: sanofi company comment for dated 2-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later was hospitalized due to severe leg pain and high blood pressure and also had 2 dvt's. A temporal relationship can be established with the product administration. Furthermore, the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products cannot be excluded.
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Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
bridgewater, NJ 08807
MDR Report Key7272506
MDR Text Key100435565
Report Number2246315-2018-00276
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/15/2018 Patient Sequence Number: 1