MAUDE Adverse Event Report: SANOFI / GENZYME CORPORATION SYNVISC ONE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Inflammation (1932); Pain (1994); Reaction (2414); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/10/2012

Event Type  Injury  

Event Description

I received synvisc one twice.The second time, about 1 yr after the first, unfortunately 1cc went into knee, 1 cc outside knee into system.I had a severe antigen/antibody reaction, according to my doctor.Despite high dose steroids etc., i've never been the same or gotten rid of the chronic pain that resulted.My question is, is there any way to get it out of my system? like chelation or some other method.The cc that went into my knee was removed within a few weeks, but of course it's not what caused my problems, the systemic cc is.I pray that you can help with some kind of advice to assist me.I read of a similar, almost identical case, an m.D.Actually, on the fda website, but it was lost to follow up.My initial reaction was in (b)(6) 2012, and i haven't been the same since, despite intensive treatment by a top rheumatologist for the intense inflammation and pain.I was a healthy active guy before this, and now have very restricted activity.I sure hope you can assist me.Thanks very much.(b)(6), patient and his presiding physician.In reading their report, it sounded very similar to my problem.However, it said after the report that it was lost to f/u, so i don't know the long term outcome of that case.My primary problem was significant pain and osteoarthritis of my right knee, which is the one injected.I had a torn cartilage back in the 70's.Surgery was done -this was just before arthroscopy- on the inside.But the orthopod was uncertain if the outside was also torn, and we opted to not do surgery.Sadly that was a big mistake, because that's where i have all of my problems.Current pictures of the inside look great, where the surgery was done, but the outside was really torn up, and i had arthroscopic surgery a couple of yrs prior to the injections to try to improve my function.Sadly, it got worse instead of better, and thus the injections were then tried.First injection went ok, modest improvement if any.Second injection by a p.A.Resulted in half going into joint 1 cc, and the second cc sadly went into my system and began this cascade of horrific problems and a significant impact on my lifestyle as a result of pain and inflammation that impairs my movement a lot.I've been living on motrin 800mg t.I.D.Or when it becomes intolerable a medrol dosepak.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SANOFI / GENZYME CORPORATION
• MDR Report Key: 10844205
• MDR Text Key: 216685824
• Report Number: MW5097911
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 69 YR
• Patient Weight: 100