MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA - ADMINISTERED IN THE ORTHOPEDIC PRACTICE OFFICE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Use of Device Problem (1670)

Patient Problems Dyspnea (1816); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 02/21/2023

Event Type  Injury  

Event Description

I received 3 dose of euflexxa in both knees for osteoarthritis.I did receive cortisone injections 3 weeks prior to beginning the euflexxa series and felt great after the first 2 doses.My knees never felt good after the third dose which occurred on (b)(6) 2023.Around (b)(6) my ability to walk and exercise was limited compared to the week before.On (b)(6) i had to abort a walk with friends because the slightest incline hurt my knees and i was getting short of breathe with light exertion.By (b)(6) my pain was increasing in my knees and i needed the aid of ibuprofen, or tylenol, or topical medications such as voltaren or arthritis pain relief cream.My provider who gave the injections said to give the medication 3 weeks to work.The date was (b)(6) and that's when my legs were extremely swollen from ankles to my knees.Increasing the amount of ibuprofen to 800 mg to start day and adding 1000 mg tylenol in the afternoon got me through the work day.Over the weekend of (b)(6) the swelling in my lower legs is improved, however, my thighs feel tight.The throbbing pain in my right knee has increased and radiates to my hip and back.Ibuprofen, aleve, and tylenol are currently only helping for a couple of hours at best, but the pain doesn't stop; it only decreases.I cannot get comfortable sitting, standing, or lying down.Walking is a challenge between the pain and stiffness in both knees.Walking or standing is limited to a short duration because the pain intensifies otherwise.Even when i sit the throbbing is so intense its intolerable and ice doesn't seem to help.Sometimes i feel like i can't catch my breath when i'm not doing much.Thank goodness for left over muscle relaxers that at least help me get some sleep.The right knee is much worse compared to the left.I have been participating in physical therapy since (b)(6) 2023, and was greatly improving until (b)(6).At my pt appointment on (b)(6) i could only tolerate massage therapy and icing of my knees.Yesterday, (b)(6) my pt appointment was much like the week before.My therapist told me she does not know how to help me any longer and suggested i see my provider.Today, (b)(6) i had enough misery and went back to my provider for an evaluation.Infection was ruled out.I did receive 2 cortisone injections, one in each knee, and pray this works.Therapy dates: 01/31/2023 - 02/14/2023.Reference report: mw5115780, mw5115781.

• Brand Name: EUFLEXXA - ADMINISTERED IN THE ORTHOPEDIC PRACTICE OFFICE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 16564273
• MDR Text Key: 311512186
• Report Number: MW5115779
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ALEVE; ARTHRITIS PAIN CREAM ; CINNAMON; COLACE; ESTRADIOL; IBUPROFEN; LEVOTHYROXINE; OSTEOFLEX; SUDAFED; TYLENOL; VITAMIN C; VOLTAREN
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White