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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOVENTUS LLC. HYALURONIC ACID INJECTION (SUPARTZ INJECTION BIOVENTUS MAKER OF SUPARTZ); ACID, HYALURONIC, INTRAARTICULAR

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BIOVENTUS LLC. HYALURONIC ACID INJECTION (SUPARTZ INJECTION BIOVENTUS MAKER OF SUPARTZ); ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problems Unexpected Therapeutic Results (1631); Patient Device Interaction Problem (4001)
Patient Problems Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Burning Sensation (2146); Arthralgia (2355); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Unspecified Vascular Problem (4441); Swelling/ Edema (4577)
Event Date 06/30/2022
Event Type  Injury  
Event Description
Hyaluronic acid injection in knees.( supartz injection bioventus maker of supartz).For years i have received at (b)(6) in (b)(6), rooster comb injections (supartz) under both kneecaps to help give my knees more cushioning.Approximately every year or under two years, i'd sec the best pa to give me injections.I did not want knee replacement because i know folks who had problems with infections, etc.Unlike the steroid injection like cortisone, that affects the knees overtime.The rooster comb injections never adversely affected me and were not a steroid.Then the unexpected happened, on thursday, (b)(6) 2022.At 11:30 am i went to get my first week injection by the same pa that has helped me for year.There's a 3 week schedule for these shots.Once a week for three weeks.(b)(6) is the best of the best.He is excellent at what he does and even teaches doctors how to give shots.He is my primary care giver in this area.Many times when i get an injection in each leg, i can't walk lo my car because my leg gets stiff so a nurse wheels me to the car and within 30 minutes or so i can drive home, a little tender for a while then back lo feeling good again.A strange thing happened that has never occurred before and it seems like the orthopedic department never experienced this.All the advice nurses and doctors i contacted for to get answers and receive help hadn't heard of this happening.One doctor.Over the phone.Told me it probably not the injections because i had them before.That it was a coincidence and maybe i have covid.It appears that covid is the new catch-all box they put everything in when they do not have any answers.I gave up and cancelled the next two scheduled injections.Bottom line.Approx.At one am on friday, (b)(6) 2022, i woke up with pain in all my joints.My wrists and fingers were swollen and stiff and weak.During the night the fingers and top of my hands felt like they were on fire inside.I tried pain cream.It seem to make it worse.Washed it off.Blood vessels al the top of my hands appeared thicker, darker, and would pulsate like something popping up and clown inside.It scared me.During the day.This did not happen just weak hands, swollen wrists and fingers painful each time i tried to open a door, pick up a dish.Write.Any movement, then i kept dropping things.My knees did not bend for three days.Took me over 30 min to gel on and off the toilet.Lo get out of or into the bed or sit a chair.I have to use an old walker to move, and to ask neighbors to go the store.Or help me with my normal chores.Today (b)(6) 2022, my knees bend somewhat, though painful, my legs go out unexpectedly from under me.I am having difficulty walking.Cannot drive my car.What scares me most is the pain and stiffness in the base of my neck.It is worsening by the day.The lower back of my head aches and at times get sharp pains that come and go in the back and sides of my head.So i cannot turn my neck/head very well because of stiffness and pain.Difficult to sleep.If this stuff is traveling through-out my body what damage it is doing? injection in my knees going every where seems impossible.Is there an antidote? am i permanently ruined? i can't trust (b)(6) for help because no one so far there had answers or offered medicines.Even one suggesting i had covid and shots were a coincidence.Sounds like cya.I need help.No one is giving it to me.So i am felling this side effect be known.If this was a bad.Batch of supartz or a changed formula, that can adversely affect people.It should be known.No one has offered tests, nor medicines, or antidote.The product was in the office cabinet taken out by the pa, assembled and injected into both knee.Boxes were discarded.Orthopedic advice nurse said they get it from the "phcy" for their use.On (b)(6) 2022, i had my first of three supartz injections, all was fine.At approximately one a.M.On (b)(6) 2022, i awoke in extreme pain in all my joints, i could not bend my knees, they were stiff like wood.My wrists and hands, and fingers were swollen, as were my ankles and feet, and more varicose veins appeared on my ankles and legs.Fingers were stiff and white like they were bloodless.However, on top of both hands, the veins were engorged thick black and they pulsated.You could see the veins pulsating up a down and it felt like hot fire inside my hands.The next day, symptoms changed.Hands very weak, tingly and fingers numb.No pulsating on top of my hands.Wrists, shoulders, very painful to use or touch.Every movement caused more pain.I couldn't open doors, hold things without dropping them, brush my hair, or do normal things.I had to call neighbors to help.I noticed the thumb areas on both hands bulged out at their base, and were extremely sore, veins prominent.Back of my neck from ear to ear and up into the lower back of my head, had shooting pains on both sides of the head and neck was stiff and difficult to move.For four days i could not bend my legs, stiff, both front and back, very painful.Relieving myself was extremely problematic, couldn't drive, do chores.Rising out of bed or sitting or getting up were almost impossible.Holding utensils to eat, they fell out of my grip.Couldn't bend to pick whatever dropped on the floor.This entire scenario was almost too much to take.Worst of all, i feared that this situation would be permanent.I couldn't take care of myself nor my pet.I'd lose my home, my pet and my independence.This is why it took me so long to write this.Update: (b)(6) 2022: i am still having issues with my hands, tingly, numb at times, and dropping things.My legs go out from under me without warning and my knees lock if i stand for very long.The sharp pains in my head are gone, neck stiffness is still there but not as extreme.Veins on top of my hands no longer engorged, nor are the ankle veins.However, there are many new veins that are now visible on my legs and ankles.I know this sounds like something out of a horror movie.Unfortunately, it happened to me.This is why i'm reporting this, in case others are at risk.
 
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Brand Name
HYALURONIC ACID INJECTION (SUPARTZ INJECTION BIOVENTUS MAKER OF SUPARTZ)
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC.
MDR Report Key15503108
MDR Text Key300896444
Report NumberMW5112320
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 Patient
Type of Report Initial
Report Date 07/05/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Patient Sequence Number1
Treatment
ACETAMINOPHEN 650MG AS NEEDED; ALLEVE; ANTI INFLAMATORY; ASPIRIN 81MG 1/DAY ; ATENOLOL 25 MG 1 /DAY; DICLOFENAC SODIUM TOPICAL GEL 1% AS NEEDED; IODINE AS NEEDED FOR PAIN ; OMEGA-3 2000 MG 3XWEEK; PANTOPRAZOLE 20MG 1 OR 2 PER DAY ; SALONPAS PATCHES AND THEIR ROLL ON ; SYNTHROID 50MCG 1 1/2 PER DAY ; VIT C 1,000 1 DAY; VIT D2 125 MCG 1/DAY; ZINC 50 MG 1 / 3X WEEK; ZOCOR 1 40MG/DAY
Patient Outcome(s) Disability;
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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