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

Lot Number 4X1B17

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

On two previous occasions, i had a series of one injection in each knee for a period of 5 weeks to alleviate pain in knee.Outcome was generally favorable with reduction of pain.In (b)(6) 2021, began another series of one injection in each knee for 5 weeks for knee pain, this time the medication was supartz fx (sodium hyaluronate) 2.5 ml.Experienced severe pain in left leg.Felt like electric shock extending from left buttock to left foot.Unable to walk for one day and difficulty walking for a few months thereafter, and moderate pain in left ham [invalid] pain gradually subsided over the course of two years to where i felt i was walking normally again.At times it felt as if i had to learn to walk all over again.Went to (b)(6) for testing.No physical cause was determined.A total of 10 tests were performed.(b)(6), (b)(6) 2022 by dr.(b)(6), m.D.(b)(6) spine 4+ views us lower extremity veins bilateral (b)(6) spine without iv contrast emg crp (c-reactive protein) uric acid cyclic citrullinated peptide antibodies, igg d-dimer ck (creatine kinase) dx knee bilateral standing 2 views.1 injection(s), 1x/wk, for 5 wks, injection to each knee.Reference reports: mw5150650, mw5150651, mw5150652, mw5150654.

• Brand Name: SUPARTZ FX
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 18572516
• MDR Text Key: 333725839
• Report Number: MW5150653
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 01/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 4X1B17
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE 10 MG 1X/DAY (ALL FOR HYPERTENSION). ; CARVEDILOL 6.25 MG 2X/DAY.; GLUCOSAMINE CHONDROITIN 1500 MG 2X/DAY FOR BACK & KNEE PAIN.; LISINOPRIL 40 MG 1X/DAY.; MELOXICAM 7.5 MG 1X/DAY.; MULTI-VITAMIN + IRON 1X/DAY.; NIACIN 250 MG 2X/DAY.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White