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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/01/2021
Event Type  Injury  
Event Description
Cannot do housework [activities of daily living impaired], legs are getting weaker [lower extremities weakness of], more hip and back pain [back pain aggravated], muscle atrophy [muscle atrophy], gait is inappropriate/ limping [gait abnormal], more pain in knee than before the injection/ increased pain/ worse pain/ more hip and back pain [arthralgia aggravated] ([pain upon movement]), minimal swelling [knee swelling], did not remove the synovial fluid before injection [wrong technique in product usage process], doctor told about synvisc one for tibial plateau fracture in left knee [off label use in unapproved indication], it doesn¿t work [device ineffective]. Case narrative: initial information received on 31-aug-2021 regarding an unsolicited valid serious case received from a nurse from united states. This case involves a (b)(6) female patient who experienced muscle atrophy, legs are getting weaker, more hip and back pain, cannot do housework, gait is inappropriate/ limping, more pain in knee than before the injection/ increased pain/ worse pain/ more hip and back pain, minimal swelling, did not remove the synovial fluid before injection, doctor told about synvisc one for tibial plateau fracture in left knee and it doesn't work while being treated with hylan g-f 20, sodium hyaluronate [synvisc one]. The patient's past medical history included back disorder and overweight. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On (b)(6) 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection (strength: 6 ml) at a dose of 6 ml once (with an unknown batch number and route) for tibial plateau fracture in left knee. In context of covid-19 crisis, information on batch number was not requested. On (b)(6) 2021 the patient developed a non-serious event "did not remove the synovial fluid before injection" (wrong technique in product usage process) same day following the first dose intake and on the same day following the last dose intake of hylan g-f 20 and sodium hyaluronate. On (b)(6) 2021 the patient developed a non-serious event "doctor told about synvisc one for tibial plateau fracture in left knee" (off label use) same day following the first dose intake and on the same day following the last dose intake of hylan g-f 20 and sodium hyaluronate. In (b)(6) 2021 the patient developed a non-serious event "cannot do housework" (loss of personal independence in daily activities) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. This event was leading to disability. In (b)(6) 2021 the patient developed a non-serious event "muscle atrophy" (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. In (b)(6) 2021 the patient developed a non-serious event "legs are getting weaker" (muscular weakness) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. In (b)(6) 2021 the patient developed a non-serious event "more hip and back pain" (back pain) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. In (b)(6) 2021 the patient developed a non-serious event "gait is inappropriate/ limping" (gait disturbance) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. In (b)(6) 2021 the patient developed a non-serious event "more pain in knee than before the injection/ increased pain/ worse pain/ more hip and back pain" (arthralgia) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. In (b)(6) 2021 the patient developed a non-serious event "when i pivot, it hurts" (pain) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. In (b)(6) 2021 the patient developed a non-serious event "minimal swelling" (joint swelling) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. In (b)(6) 2021 the patient developed a non-serious event "it doesn't work" (device ineffective) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of hylan g-f 20 and sodium hyaluronate. It was reported "i am a nurse. Last summer, i had a tibial plateau fracture in my left knee. I had two steroid injections that did not work. The first two injections lasted two weeks. Then, my doctor told me about synvisc-one. I had a synvisc-one injection on (b)(6) 2021. Now, i have more pain in my knee then i did before the injection (synvisc-one). I am (b)(6), and i can't do my housework. I am pissed at this doctor. I am wondering how long it takes to see results with synvisc-one. I expected some relief by now. When i went in to get the synvisc-one injection, my doctor told me that i had some synovial fluid in my knee. I told him that the fluid had been there. He probably used a 20 gauge needle and put the needle in the synovial sac. He did aspirate about 2 cc of fluid but then he let the fluid go back into the knee. He left the needle in the knee. I thought he was just checking the placement. He did not freeze the area at all. It (synvisc-one) is a little viscous so i could feel it going in. He injected the 6 cc of the synvisc-one. I have more pain now. By the time i walk to my mailbox and back, i have increased pain. I want him (doctor) to get the bone fragments and take the arthritic cartilage out. I do not want surgery. I have had no relief, but i am in worse pain. I am not interested in trying another injection. I need to find another doctor. I can't do shopping without limping. I have some voltaren to take but it doesn't work. I also have some back issues that i have had. I have a high tolerance for pain. I have a constant 6 or 7 on a pain scale. I have to be careful because when i pivot, it hurts. I feel like i have sensation that my knee is going to give out. I have to watch every step i take. It is driving me up a tree. I use an ace wrap and that helps some with stability but not the pain. I have no heat, fever, and i have minimal swelling. My knee is shiny though. I haven't been up on it much this morning. I don't take pain medicine. My gait is inappropriate so now i have more hip and back pain. I do believe he (doctor) made a mistake in the procedure because he did not remove the synovial fluid before my injection. So, there was nowhere for the synvisc-one to go. I am starting to have muscle atrophy. I can't carry a lot because i am afraid that i will have to throw everything down and brace myself. I am going to call my doctor for a second time and tell him that this did not work and ask him what the next plan will be. I have had a corticosteroid injection with lidocaine in the past and that was wonderful of course. I am overweight, but i am not obese. My legs are getting weaker. I have an ice pack on my knee and a heating pad on my back. This isn't working. " action taken with hylan g-f 20, sodium hyaluronate (synvisc one) was not applicable. The patient was treated with diclofenac sodium (voltaren [diclofenac sodium]) for arthralgia. It was not reported if the patient received a corrective treatment for the events (cannot do housework, minimal swelling, more hip and back pain, gait is inappropriate/ limping, muscle atrophy, legs are getting weaker, did not remove the synovial fluid before injection, doctor told about synvisc one for tibial plateau fracture in left knee, it doesn't work). At time of reporting, the outcome was not recovered / not resolved for the event more pain in knee than before the injection/ increased pain/ worse pain/ more hip and back pain, was not recovered / not resolved for the event cannot do housework, was not recovered / not resolved for the event minimal swelling, was not recovered / not resolved for the event more hip and back pain, was not recovered / not resolved for the event gait is inappropriate/ limping, was not recovered / not resolved for the event muscle atrophy, was not recovered / not resolved for the event legs are getting weaker, was unknown for the event did not remove the synovial fluid before injection, was unknown for the event doctor told about synvisc one for tibial plateau fracture in left knee and was unknown for the event it doesn't work. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the directive 2001/83/ec and module vi of the good pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
MDR Report Key12429042
MDR Text Key282292128
Report Number2246315-2021-00144
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/06/2021 Patient Sequence Number: 1
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