MAUDE Adverse Event Report: SEIKAGAKU CORPORATION SUPARTZ FX; ACID, HYALURONIC, INTRAARTICULAR

Model Number 89130-4444-01

Device Problem Insufficient Information (3190)

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  

Manufacturer Narrative

This is a definitive report.This case is received by bioventus on (b)(6) 2022 via e-mail from the fda as (b)(4) dated (b)(6) 2022 and it was forwarded to manufacturer.We are not able to investigate in details because no contact information is provided.We selected the code of 4316 (appropriate term/code not available) for h.6 manufacturer evaluation conclusion code because some adverse events in this report were not listed in the package insert.

Event Description

For years, a patient had received supartz fx injections under both kneecaps to help give the knees more cushioning.The supartz fx injections never adversely affected the patient.Then the unexpected happened.(b)(6) 2022 at 11:30 am, the patient went to get the first week injection.There's a 3-week schedule for these shots, once a week for three weeks.(b)(6) 2022 approx.1:00 am, the patient woke up with pain in all the joints.The wrists and fingers were swollen, stiff and weak.During the night, the fingers and top of the hands felt like they were on fire inside.The patient tried pain cream.It seems to make it worse.Washed it off.Blood vessels at the top of the hands appeared thicker, darker, and would pulsate like something popping up and clown inside.During the day, this did not happen just weak hands, swollen wrists and fingers painful each time the patient tried to open a door, pick up a dish, write.Any movement, then the patient kept dropping things.The knees did not bend for three days.Took the patient over 30 min to get on and off the toilet.To get out of or into the bed or sit a chair.The patient had to use an old walker to move, and to ask neighbors to go the store, or help the patient with the normal chores.(b)(6) 2022 hands very weak, tingly and fingers numb.No pulsating on top of the hands.Wrists, shoulders, very painful to use or touch.Every movement caused more pain.The patient could't open doors, hold things without dropping them, brush the hair, or do normal things.The patient had to call neighbors to help.The patient noticed the thumb areas on both hands bulged out at their base, and were extremely sore, veins prominent.Back of the neck from ear to ear and up into the lower back of the head, had shooting pains on both sides of the head and neck was stiff and difficult to move.For four days the patient could not bend the legs, stiff, both front and back, very painful.Relieving her/himself 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 the grip.Couldn't bend to pick whatever dropped on the floor.2022 -07-05 - the patient was still having issues with the hands, tingly, numb at times, and dropping things.The knees bend somewhat, though painful, the legs go out unexpectedly from under the patient.The patient was having difficulty walking.Cannot drive a car.What scares the patient most is the pain and stiffness in the base of the neck.It is worsening by the day.The lower back of the head aches and at times get sharp pains that come and go in the back and sides of the head.So the patient could not turn the neck/head very well because of stiffness and pain.Difficult to sleep.The patient could not trust the hospital for help because no one so far there had answers or offered medicines.All the advice nurses and doctors the patient contacted for to get answers and receive help hadn't heard of this happening.One doctor, over the phone, told the patient it probably not the injections because the patient had them before.That it was a coincidence and maybe the patient was having covid.This is why the patient is reporting this to fda, in case others are at risk.

• Brand Name: SUPARTZ FX
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• Manufacturer (Section G): SEIKAGAKU CORPORATION - TAKAHAGI PLANT; 258-5, aza-matsukubo; oaza-akahama; takahagi-shi, ibaraki 318-0 001; JA 318-0001
• Manufacturer Contact: pharmacovigilance dept ; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005 ; JA 100-0005
• MDR Report Key: 15747682
• MDR Text Key: 303233731
• Report Number: 9612392-2022-00006
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 89130-4444-01
• Device Catalogue Number: 7156-4444
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability