Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL 89122-0724-20Recalls & reported problems
Fidia Farmaceutici SPA · Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M71389122072420A1), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem
THIS IS A SPONTANEOUS REPORT RECEIVED BY (B)(4), INITIAL IMPORTER FOR AND WHOLLY OWNED SUBSIDIARY OF FIDIA FARMACEUTICI (B)(4) AS REPORTED BY (B)(6) SPECIALTY PHARMACY TO THE IMPORTER AND FDA, (FDA MW5087768). A (B)(6) YEAR OLD FEMALE PATIENT WAS TREATED WITH HYALGAN 20MG/2ML (HYALURONATE SODIUM) SOLUTION FOR INARTICULAR INJECTION, 20MG WEEKLY STARTING (B)(6) 2018. DEVICE LOT NUMBER WAS B09850, EXPIRY 26-JUL-2020. ON AN UNSPECIFIED DATE THE PATIENT STATED HER LEFT KNEE STARTED TO HURT. THE INITIAL REPORT INDICATED THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS HOSPITALIZATION. THE EVENT WAS REPORTED AS SERIOUS DUE TO HOSPITALIZATION. THE PRIMARY SOURCE DESCRIBED THE EVENT AS "PATIENT INFORMED HER LEFT KNEE STARTED TO HURT".
Patient problems: Pain
MAUDE report 8817888 ↗
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- 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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