Arthrex® 82197-0721-16Recalls & reported problems
Arthrex, Inc. · SynoJoynt® 1% Sodium Hyaluronate · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867413689), received between Oct 14, 2024 and May 1, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Expiration Date Error” (1 report).
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
- Expiration Date Error1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Expiration Date Error; Expiration Date Error
ON 3/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 82197-0721-16 SYNOJOYNT 1% SODIUM HYALURONATE WAS USED IN A PATIENT PAST ITS EXPIRATION DATE. THE INJECTION WAS ON (B)(6) 2025, AND THE PRODUCT EXPIRED ON 3/14/2025. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21941345 ↗InjuryOct 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON 9/13/2022, IT WAS REPORTED BY A PATIENT VIA PHONE THAT SHE HAD A SIDE EFFECT AFTER HAVING RECEIVED A SECOND SYNOJOYNT 1% SODIUM HYALURONATE KNEE INJECTION ON (B)(6) 2022. HER FIRST KNEE INJECTION PROCEDURE ON (B)(6) 2022 WENT FINE, AND SHE HAD NO ISSUES OR SIDE EFFECTS. ON (B)(6) 2022, AFTER THE SECOND KNEE INJECTION PROCEDURE, SHE DEVELOPED THAT NIGHT A UTI WHICH WAS ACCORDING TO HER DOCTOR A KNOWN SIDE EFFECT. HER THIRD INJECTION IS SCHEDULED FOR (B)(6) 2022, BUT SHE IS HESITANT TO CONTINUE WITH THE TREATMENT AND WILL SEEK MEDICAL ADVICE FROM HER OBYGN PRACTITIONER FIRST. NO ACTION WAS REQUESTED, SHE JUST WANTED TO REPORT THE COMPLAINT.
Patient problems: Unspecified Infection
MAUDE report 20438886 ↗
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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