MAUDE Adverse Event Report: FERRING USA EUFLEXXA; HYALURONIC ACID

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544)

Event Date 08/17/2016

Event Type  Injury  

Event Description

I received three weekly lateral knee injections of euflexxa for joint pain.Four weeks later, i still have swollen, painful joints and legs.The pain keeps me awake all night, i have trouble walking up and down stairs, and i can't sit or stand for any length of time.I had synvisc injected two years ago and had none of these side effects.I am reporting this because i question the data i see online showing that euflexxa has fewer side effects than other forms of hyaluronic acids.There are many complaints from pts online in various forums that would suggest otherwise.I can't find any info about how to treat these side effects and i fear that there is no treatment.Date the person first started taking or using the product: (b)(6) 2016.Date the person stopped taking or using the product: (b)(6) 2016.Knee pain.

• Brand Name: EUFLEXXA
• Type of Device: HYALURONIC ACID
• Manufacturer (Section D): FERRING USA
• MDR Report Key: 5982951
• MDR Text Key: 55930769
• Report Number: MW5065057
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BIOTIN; VIT D
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Weight: 59