Monovisc 690016Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00817337000104), received between Jan 9, 2025 and Aug 21, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  A distributor reported a Monovisc related event involving a patient with a pseudoseptic reaction, reporting stiffness and swelling after knee injections. The device was discarded and was not available for return. The event was reported to have occurred in an unknown amount of days post knee injection. Patient outcome or consequences were indicated, but additional medical intervention, and whether revision surgery or hardware removal was required is unknown. Reported complaint terms included swelling, musculoskeletal stiffness, infection, and minor injury. This case is still under investigation. A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

  Patient problems: Administration Site Reaction; Arthritis; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 50368107 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  A DISTRIBUTOR REPORTED THE FOLLOWING TO ANIKA VIA ANIKA CUSTOMER SERVICE: A PATIENT REACTION TO MONOVISC INJECTIONS OCCURRED IN THE ORTHOPEDIC OFFICE RECENTLY. PATIENT HAD A SIGNIFICANT KNEE SYNOVITIS: WHITE COUNT OF 62,500 WITH 90% NEUTROPHILS, CULTURES NEGATIVE."

  Patient problems: Medical device site infection

  MAUDE report 25890036 ↗
• InjuryOct 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED IN THIS REPORT. ON 12SEP2025, THE FOLLOWING WAS REPORTED TO ANIKA VIA MEDWATCH REPORT NUMBER (MW5174391) EVENT: "PATIENT RECEIVED MONOVISC BRAND NAME INJECTION ON TO THE RIGHT KNEE FOR OSTEOARTHRITIS. PATIENT PREVIOUSLY RECEIVED MONOVISC INJECTION ON (REDACTED) 2025 AND DID NOT EXPERIENCE SIDE EFFECTS FROM THAT INJECTION. ON (B)(6) 2025, PATIENT PRESENTED WITH SWELLING OF RIGHT KNEE UP TO [RIP HIP]. PATIENT WAS EXPERIENCING SHARP PAINS IN RIGHT KNEE AT THIS TIME AND REQUIRED A WHEELCHAIR FOR ASSISTANCE. ASPIRATED 25 ML OF SANGUINEOUS FLUID FOR PAIN RELIEF. PATIENT PRESENTED ON (REDACTED) 2025 WITH DECREASED SWELLING AND INCREASED RANGE OF MOTION BACK IN HER RIGHT KNEE." IT WAS INDICATED THAT MONOVISC WAS USED FOR THE PROCEDURE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 23247818 ↗
• InjuryOct 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED IN THIS REPORT. ON 12SEP2025 THE FOLLOWING WAS REPORTED TO ANIKA VIA MEDWATCH REPORT NUMBER (MW5174192) EVENT: "PATIENT RECEIVED INJECTION ON (B)(6) 2025 TO RIGHT KNEE. PATIENT REPORTED UNABLE TO PUT WEIGHT ON RIGHT KNEE ON (B)(6) 2025. PRIMARY OSTEOARTHRITIS OF RIGHT KNEE. IT WAS INDICATED THAT MONOVISC WAS USED FOR THE PROCEDURE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THERE WAS NO MALFUNCTION REPORTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT RECEIVED UNPLANNED MEDICAL INTERVENTION.

  Patient problems: Arthritis

  MAUDE report 23247202 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED IN THIS REPORT. ON 10SEP2025 THE FOLLOWING WAS REPORTED TO ANIKA VIA MEDWATCH REPORT NUMBER (MW5174193) EVENT: PATIENT REPORTED SHE HAD GASTRIC BYPASS SURGERY. FREQ: INJECT 1 SYRINGE INTRA-ARTICULARLY INTO THE RIGHT KNEE ONCE. IT WAS INDICATED THAT MONOVISC WAS USED FOR THE PROCEDURE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THERE WAS NO MALFUNCTION REPORTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT RECEIVED UNPLANNED MEDICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 23209352 ↗
• MalfunctionApr 7, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 25MARCH2025 MEDWATCH (MW5167646) WAS RECEIVED BY ANIKA. IT WAS REPORTED THAT WHEN PRESSING DOWN ON THE MONOVISC SYRINGE PLUNGER, ONE OF THE BARREL FINGER FLANGES BROKE OFF DURING THE KNEE INJECTION ON A PATIENT OF UNKNOWN AGE AND DEMOGRAPHIC. THE HCP ATTEMPTED TO DRAW BACK ON THE PLUNGER AFTER EXPERIENCING RESISTANCE WITH THE INITIAL ATTEMPT AT DELIVERY OF THE SYRINGE CONTENTS. THE HCP USED A 22-GAUGE 3.5-INCH SYRINGE. THERE WAS NO DEFECT WITH THE DEVICE OR PACKAGING OBSERVED PRIOR TO THE USE OF THE DEVICE. THERE WAS NO NEGATIVE PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785410 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON (B)(6) 2024 IT WAS REPORTED THAT AFTER A PATIENT OF UNKNOWN AGE AND DEMOGRAPHIC WAS TREATED WITH MONOVISC IN THE RIGHT KNEE THE PATIENT REPORTEDLY WAS UNABLE TO WALK AND REPORTED PAIN. THE PATIENT WAS SUBSEQUENTLY PLACED ON A STEROID (COURSE / BRAND UNKNOWN) TO TREAT THE PATIENT'S INFECTION. THE PATIENT ALSO HAD 90CC OF FLUID DRAINED A WEEK AFTER THE INJECTION. THERE WAS NO REPORT OF ANY DEVICE OR PACKAGING DEFICIENCY PRIOR TO THE TREATMENT. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: Unspecified Infection

  MAUDE report 21112816 ↗