MonoviscRecalls & reported problems across all models

We found 2 models of Monovisc by Anika Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2016 and Aug 21, 2026 — classified as 1 death, 32 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Monovisc problems

Monovisc models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Monovisc 690-016

  Acid, Hyaluronic, Intraarticular
  1 death31 reports
• Monovisc 690016

  Acid, Hyaluronic, Intraarticular
  7 reports

Recent Monovisc adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryFeb 23, 2026Insufficient Device Problem Information

  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 05FEB2026, THE DISTRIBUTOR REPORTED THE FOLLOWING TO ANIKA WE RECEIVED AN ANIKA PRODUCT COMPLAINT WITH THE FOLLOWING EVENT DESCRIPTION EVENT DATE WAS UNKNOWN FOR MONOVISC 4 ML US - 690016 LOT NUMBER UNKNOWN. THE DEVICE RETURN IS UNKNOWN. EVENT DESCRIPTION: PATIENT STATES THEY HAVE A PINCHED NERVE. PATIENT FEELS NERVE ISSUE IMPROVED BUT HAVE NO CARTLIDGE-BONE ON BONE. DOCTOR INJECTED PT WITH MONOVISC. PT HAS PROBLEMS WITH MOBILITY AND PAIN. AFTER INJECTION THEY EXPERIENCED PAIN, A FALL, WENT TO ER AND WALKED AROUND 6-8 MONTHS, NO CARTLIDGE LEFT. ADDITIONAL INFORMATION IS BEING SOLICITED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Nervous System Problem

  MAUDE report 24414643 ↗
• MalfunctionDec 29, 2025Component Missing; Component Missing

  ON 09DEC2025 MEDSUN MDR REPORT 3500A (B)(4) WAS RECEIVED BY ANIK. IT WAS REPORTED THAT THE BLUE FLANGE PART OF THE SYRINGE FOR 2 MONOVISC INJECTABLES WERE MISSING WHEN THE PACKAGING WAS OPENED. MONOVISC 4 ML US - 690016: LOT NUMBER: 0000012064 EXPIRATION DATE: JAN-2028. DEVICE NOT AVAILABLE FOR RETURN. COMPLAINANT OFFICE BECAME AWARE OF THE ISSUE MAY 2025. OFFICE DID NOT OBTAIN A PICTURE OF THE SYRINGE MISSING THE FLANGE. THE OFFICE STAFF DID NOT NOTE ANY UNUSUAL APPEARANCES TO THE DEVICE (BESIDES MISSING THE BLUE FLANGE). THERE WAS NO DEFECT WITH THE DEVICE OR PACKAGING OBSERVED PRIOR. THERE WAS NO NEGATIVE PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907448 ↗
• MalfunctionDec 9, 2025Component Missing

  THE BLUE FLANGE PART OF THE SYRINGE FOR 3 ORTHOVISC AND 2 MONOVISC INJECTABLES WERE MISSING WHEN THE PACKAGING WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756839 ↗
• 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 ↗
• InjuryJun 18, 2025Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; 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 13JUNE2025, A MEDWATCH REPORT WAS RECEIVED FROM THE FDA. A 77-YEAR-OLD FEMALE PATIENT REPORTED RECEIVING A MONOVISC (LOT NUMBER: UNKNOWN) INJECTION (TREATMENT COURSE, KNEES) ON OR ABOUT ON (B)(6) 2024. AFTER RECEIVING THE INJECTIONS, THE PATIENT REPORTED EXPERIENCING BACK PAIN, AND SOME AMBULATORY DIFFICULTY. THERE WAS NO MALFUNCTION REPORTED. PATIENT COMORBIDITIES ARE UNKNOWN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT RECEIVED UNPLANNED MEDICAL INTERVENTION. THERE WAS NO CONTACT INFORMATION TO OBTAIN ADDITIONAL INFORMATION FROM THE PATIENT OR CLINIC.

  Patient problems: Ambulation or Postural Difficulties; Back pain

  MAUDE report 22285987 ↗
• 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 ↗
• MalfunctionNov 23, 2021Break

  ON 30SEPT2021 IT WAS REPORTED TO ANIKA THAT DURING A KNEE INJECTION, THE MONOVISC SYRINGE BROKE. THERE WAS NO ART OF THE SYRINGE TOUCHING THE PATIENT. THERE WAS NO PATIENT IMPACT REPORTED. A REPLACEMENT MONOVISC SYRINGE WAS USED TO COMPLETE THE TREATMENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864347 ↗
• InjuryJun 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SEE H10 FOR PLANT INVESTIGATION.

  Patient problems: Administration Site Reaction

  MAUDE report 11962895 ↗
• InjuryMay 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, FDA FORWARDED THE MEDWATCH NUMBER MW5100154 TO ANIKA INC. IT WAS REPORTED THE PATIENT TRIED AND FAILED MEDICATION. ADDITIONAL INFORMATION WAS SOLICITED TO THE CUSTOMER, NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: Inadequate Pain Relief

  MAUDE report 11903088 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED DURING ROUTINE FOLLOW UP THAT THIS EVENT WAS PREVIOUSLY REPORTED ON MDR# 202FLS000102.

  Patient problems: Arrhythmia; Eye Pain; Headache; Hot Flashes/Flushes

  MAUDE report 11787296 ↗

Other Anika Therapeutics, Inc. products

• Orthovisc2 models · 45 reports