MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC GEL INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Model Number J7324

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Fever (1858); Pain (1994); Unspecified Respiratory Problem (4464)

Event Date 11/06/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 i fell in my back yard on both knees.I went to a clinic that i had been to before and they x-ray both knees telling me i had stage 4 arthritis in both knees and that i needed to start the series of gel injections immediately, they got them preapproved within mins through my insurance.They told me i needed a series of 5 shots in each knee, 1 in one on one day then a couple days later, do the other and repeat for 5 weeks.I was scared and unsure about what to do, they tried to reassure me, it's all natural hyaluronic acid your body makes.So i just let them do one cortisone shot in my right knee that day.My right knee was the one hurting worse.I went back in on "(b)(6)" and told them i deliver mail and i could not do both knees at the same time.We could try the right knee and see how it goes.They put me on a table and did an x-ray and inserted what i assume was the orthovisc gel, then they assured me no worries i can go straight back to work that day, no rest needed, no need to stay off that i could actually make my appointment for 7 am and then go deliver mail.I am on my feet for 10 to 12 hours a day most days.They said you will begin to have some relief now after these injections.I got home and my knee hurt actually my entire leg hurt from my hip to my ankle.When i would shower the area around my knee felt funny, when i would walk it felt off and pain was present.I went back in on "(b)(6)" and immediately informed them that something didn't feel right and i didn't like how it felt.I was told to stick with it that it will get better, to give it a couple more weeks.We did another injection that day on the table, took x-ray injected the gel.I was told ok resume regular activity.And on my way.Still weird feeling and pain present.I was thinking this can't be right.On "(b)(6)" i went back in still explaining how it didn't feel good and something was wrong.Once again i was told it just takes a little time.So on the table x-ray taken and gel injected.This time was a little different, i almost couldn't bend my leg to get in my car.Constant pain.Every day i would get up and think can i put weight on this leg today? on "(b)(6)" i went to work and before noon, i was feeling miserable.I had a high fever, difficulty breathing, fatigue like the worst flu ever.I finished my work and was barely able to drive home.I got home and crawled into bed for friday and saturday i dealt with fever and flu like symptoms on saturday night, i broke out from head to toe with a rash and had trouble breathing, couldn't sleep, i went to the er.An allergic reaction to the orthovisc injections a rare but serious side effect.The next day i had a knot come up above my right knee.From that day til today i have woke up every morning in pain.I was barely able to make it through christmas delivery at work.Crying before i the end of the day and getting help from other carriers just to be able to finish my route.This has ruined the last 6 months of my life.Not able to decorate for christmas and enjoy time with my children.Not able to walk my dogs a tenth of a mile.I had 4 ortho surgeons, a sports medicine place, a dermatologist, a general surgeon, 5 x-rays, 2 mris, an ultrasound with no help and no relief.The knot gets worse if i'm on my feet but doesn't go away if i stay off.I have been out of work for almost 3 months now.I was told by every doctor that i don't have stage 4 arthritis that i don't have arthritis at all, and those shots wouldn't have ever help me.But i can't get anyone to acknowledge this knot or tell me how to get rid of it and be able to walk again with out pain.No one has taken a sample of it or aspirated or offered to try to find out what it is.My question to you is if this is considered a medical device how do i get it removed from my leg.I have an appointment soon with the mayo clinic i pray to find help and relief and resume my normal life soon.I am loosing hope and loosing patience.I have exhausted all of my leave at work at this point.Reference report mw5116022.

• Brand Name: ORTHOVISC GEL INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 16629173
• MDR Text Key: 312212596
• Report Number: MW5116023
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J7324
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: A COCHLEAR IMPLANT IN RIGHT EAR. ; BREAST IMPLANTS. ; CALCATONIN SALMON.; DIM VITAMIN. ; NACIANMIDE VITAMIN.; NASAL SPRAY.; NP THYROID. ; PROGESTERONE.
• Patient Outcome(s): Required Intervention; Other; Disability
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White