Gel-One® Cross-linked Hyaluronate 00-1111-001-00 (UDI 00087541300912)Recalls & reported problems
Seikagaku Corporation · Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 1
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00087541300912), received between Jul 24, 2019 and Jul 2, 2020 — classified as 1 death, 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
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
- Insufficient Device Problem Information3
- Patient-Device Incompatibility3
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Material Twisted/Bent1
Patient problems
- Hypersensitivity/Allergic reaction2
- Arthralgia1
- Bone Fracture(s)1
- Breast Neoplasm1
- Death1
- Myocardial Infarction1
- Pain1
- Skin Inflammation1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
DeathJul 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON 2020-UNK - A FEMALE PATIENT RECEIVED GEL-ONE INJECTION INTO THE KNEE FOR OSTEOARTHRITIS. ON (B)(6) 2020 - SHE PASSED AWAY.
Patient problems: Death
MAUDE report 10223560 ↗InjuryMay 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
UNK - A FEMALE PATIENT RECEIVED GEL-ONE INJECTION INTO THE KNEE FOR OSTEOARTHRITIS. THE EXPIRATION DATE OF THE PRODUCT WAS 2019-11-25. ON (B)(6) 2020 - THE PATIENT WAS HOSPITALIZED FOR SURGERY AFTER FRACTURING HER HUMERUS ON 2020-[MASKED].
Patient problems: Bone Fracture(s)
MAUDE report 10102910 ↗InjuryApr 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
UNK: A FEMALE PATIENT RECEIVED GEL-ONE INJECTION INTO THE KNEE FOR OSTEOARTHRITIS. 2020-UNK : SHE WAS HOSPITALIZED DUE TO HEART ATTACK. (B)(6) 2020: SHE HAS MEDICATIONS.
Patient problems: Myocardial Infarction
MAUDE report 10005103 ↗InjuryDec 20, 2019Patient-Device Incompatibility
ON (B)(6) 2019 - A PATIENT RECEIVED GEL-ONE INJECTION IN THE KNEE AT THE PATIENT'S RHEUMATOLOGIST. THIS WAS THE THIRD INJECTION IN 2 YEARS. THE DOCTOR FIRST CLEANED THE AREA WITH ALCOHOL AND THEN SHE SPRAYED A TOPICAL NUMBING SPRAY (GEBAURER ETHYL CHLORIDE). THE DOCTOR THEN INJECTED THE GEL-ONE IN THE KNEE. THE DOCTOR ASKED THE PATIENT SEVERAL TIMES IF THE PATIENT WAS OK SINCE IT WAS HARDER FOR THE MEDICINE TO BE INJECTED THIS TIME. AFTER THE FULL INJECTION WAS ADMINISTERED, THE PATIENT STARTED FEELING LIGHTHEADED, SEEING STARS AND WAS REALLY FAINT AND THEN THE THROAT STARTED FEELING WEIRD, THE PATIENT STARTED WHEEZING AND HAVING A PROBLEM BREATHING. THE PULSE WAS VERY LOW. THE DOCTOR CALLED 911 SHE ADMINISTERED BENADRYL BY INJECTION AND ALSO, A STEROID BY INJECTION AND NOTHING WAS HELPING SO THEY ENDED UP USING THE PATIENT'S EPI-PEN (THE PATIENT IS ALLERGIC TO BEES). THE PATIENT WAS STABLE AND THEN TAKEN TO A HEALTHCARE FACILITY FOR OBSERVATION. THE PATIENT SAW AN ALLERGIST.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 9503583 ↗MalfunctionDec 19, 2019Patient-Device Incompatibility
NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation; Tingling; Urticaria
MAUDE report 9496202 ↗InjuryNov 28, 2019Adverse Event Without Identified Device or Use Problem
2019-UNK - A FEMALE PATIENT, WHO RECEIVED GEL-ONE INJECTION, REPORTED THAT SHE WAS DIAGNOSED WITH BREAST CANCER.
Patient problems: Breast Neoplasm
MAUDE report 9390520 ↗InjurySep 18, 2019Patient-Device Incompatibility
NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 9081256 ↗InjuryJul 24, 2019Break; Detachment of Device or Device Component; Material Twisted/Bent
NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Arthralgia
MAUDE report 8822150 ↗
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
- Monovisc 690016Anika Therapeutics, Inc. · Acid, Hyaluronic, Intraarticular7 reports
- Orthovisc 630254Anika Therapeutics, Inc. · Acid, Hyaluronic, Intraarticular5 reports
- GELSYN-3 GS3111Ibsa Farmaceutici Italia Srl · Acid, Hyaluronic, Intraarticular4 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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