SUPARTZ FX sodium hyaluronate 71564444Recalls & reported problems
Bioventus LLC · SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution). · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10389130444418), received between Nov 6, 2024 and Nov 8, 2024 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Bacterial Infection1
- Pain1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT INJECTED WITH SUPARTZ IN BOTH KNEES EXPERIENCED SEVERE PAIN AND SWELLING 2 DAYS POST INJECTION. THE PATIENT HAD A FOLLOW UP VISIT WITH THERE PHYSICIAN ON (B)(6) 2024, WHERE X-RAYS WERE TAKEN AND SHOWED JOINT EFFUSION. THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR FURTHER TREATMENT. THE PATIENT WAS ADMITTED THE SAME DAY AND DISCHARGED 14 DAYS LATER. THE PATIENT WAS DIAGNOSED WITH SEPTIC ARTHRITIS WITH CULTURES SHOWING A STREPTOCOCCAL INFECTION. TREATMENT WHILE IN THE HOSPITAL IS UNKNOWN. CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20640105 ↗InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024 - A MALE PATIENT RECEIVED SUPARTZ FX INTO BILATERAL KNEES WITH 21G 2" NEEDLE UNDER FLUOROSCOPY. 1.5CC OMNIPAQUE WAS INJECTED FOR ARTHROGRAM. 4CC 1% LIDOCAINE WAS USED FOR ANESTHESIA. ON (B)(6) 2024 - THE PATIENT EXPERIENCED SEVERE PAIN, DIFFICULTY WALKING/STANDING, INCREASED SWELLING. ON (B)(6) 2024 - THE PATIENT RETURNED TO THE PHYSICIAN. X-RAYS WERE TAKEN AND CULTURES WERE DRAWN. THE PHYSICIAN WAS CONCERNED OF SEPTIC ARTHRITIS AND SUGGESTED THE PATIENT GO TO THE EMERGENCY ROOM. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2024. THE PATIENT WAS DIAGNOSED WITH STREPTOCOCCAL SEPTIC ARTHRITIS. HE WAS TREATED PER INFECTIOUS DISEASE, CARDIOLOGY, ORTHOPEDICS. ON (B)(6) 2024 - THE PATIENT WAS REPORTED TO BE IMPROVING. THE CURRENT STATUS: FOLLOWING WITH ORTHOPEDICS WITH POSSIBLE KNEE REPLACEMENTS IN THE FUTURE.
Patient problems: Bacterial Infection
MAUDE report 20616426 ↗
Other Acid, Hyaluronic, Intraarticular devices
- Orthovisc 630-254Anika Therapeutics, Inc. · Acid, Hyaluronic, Intraarticular2 deaths40 reports
- Monovisc 690-016Anika Therapeutics, Inc. · Acid, Hyaluronic, Intraarticular1 death31 reports
- DUROLANE 1082020Bioventus LLC · Acid, Hyaluronic, Intraarticular16 reports
- Gel-One® Cross-linked Hyaluronate 00-1111-001-00Seikagaku Corporation · Acid, Hyaluronic, Intraarticular13 reports
- GenVisc® 850 sodium hyaluronate 50653-0006-01Avanos Medical, Inc. · Acid, hyaluronic, intraarticular12 reports
- Gel-One® Cross-linked Hyaluronate 00-1111-001-00Seikagaku Corporation · Acid, Hyaluronic, Intraarticular1 death8 reports
- Monovisc 690016Anika Therapeutics, Inc. · Acid, Hyaluronic, Intraarticular7 reports
- Orthovisc 630254Anika Therapeutics, Inc. · Acid, Hyaluronic, Intraarticular5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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