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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNVISC ONE; SODIUM HYALURONATE
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SYNVISC ONE; SODIUM HYALURONATE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Reaction (2414)
Event Date 12/11/2017
Event Type  Injury  
Event Description
A (b)(6) y/o female who presented to the (b)(6) ed on (b)(6) 2017 due to severe bilateral knee pain following synvisc one injection on (b)(6) 2017 in the pain clinic.The pt's pain was focal to both knee joints made acutely worse with palpation and ranging of the knees, right worse than left.The pt has noted effusion of the knee with out-pouching in the superolateral aspects.Concern for reaction to the synvisc (intra-articular) or extravasation of the material outside the knee joint cause swelling and pain.X-rays and labs were normal.She has no systemic symptoms of infection and knee's were not overtly concerning for septic joint.Knees were aspirated (20 cc total for both knees) with clear fluid that was aseptic.Overall felt to likely be a pseudoseptic knee reaction to the synvisc one.Treatment with ice, compression, and nsaids.She was seen in the clinic 2 days later, and from there underwent further aspiration and injection with intra-articular steroids to reduce inflammation.
 
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Brand Name
SYNVISC ONE
Type of Device
SODIUM HYALURONATE
MDR Report Key7138771
MDR Text Key95649523
Report NumberMW5074167
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 Health Care Professional
Type of Report Initial
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age65 YR
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