Monovisc 690-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886705025183), received between Aug 10, 2016 and Feb 23, 2026 — classified as 1 death, 26 injuries, 4 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, 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem

  MEDWATCH MW5098536 WAS FORWARDED TO ANIKA THERAPEUTICS BY THE FDA. THE PATIENT REPORTED THAT DURING A MONOVISC INJECTION, THE PATIENT EXPERIENCED PRESSURE AND PAIN. PATIENT CONTINUED EXPERIENCING PAIN WEEKS AFTER THE INJECTION. THE PATIENT RETURNED BACK TO THE PHYSICIAN AND RECEIVED AN MRI WHICH SHOWED THAT THE PATIENT HAD A STRESS FRACTURE IN THE RIGHT KNEE. NO ADDITIONAL INFORMATION WAS PROVIDED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 11680464 ↗
• InjuryMar 31, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THIS IS A FOLLOW UP SUBMISSION. SEE H10 FOR PLANT INVESTIGATION.

  Patient problems: Arthralgia; Arthritis; Swelling/ Edema

  MAUDE report 11598948 ↗
• MalfunctionMar 31, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A KNEE INJECTION THE MONOVISC INJECTION BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION

  Patient problems: Insufficient Information

  MAUDE report 11598188 ↗
• DeathFeb 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTER CALLED ON 24 JANUARY2020 TO CUSTOMER SERVICE, THE CUSTOMER SERVICE REPORT STATE THAT THE REPORTER EXPERIENCE REACTION, FEVER AND REDNESS AFTER A MONOVISC TREATMENT. UPDATE INFORMATION LEADING TO MDR FILING RECEIVED ON 29 JANUARY 2020 FOLLOWUP CALL WAS MADE TO THE REPORTER FOR ADDITIONAL INFORMATION ON 29JAN2020, THE REPORTER MENTIONED THAT THE COMPLAINTS WAS ON BEHALF OF HIS BROTHER WHO DIED TWO DAYS AFTER MONOVISC TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE REPORTER.

  Patient problems: Death

  MAUDE report 9660241 ↗
• InjurySep 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INITIAL REPORT (B)(6) 2019. "IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT THE PATIENT HAD A REACTION TO MONOVISC INJECTION. THE PATIENT RECEIVED AN INJECTION IN HER RIGHT KNEE AND THEN BEGAN TO HAVE A ITCHY, SCRATCHY THROAT AROUND 30-60 MINUTES AFTER THE INJECTION. THE PATIENT WAS STILL IN THE BUILDING SO THEY TOOK HER IMMEDIATELY TO THE ER. SHE'S NOT HAD MONOVISC IN THE PAST AND DID NOT KNOW OF ANY ALLERGIES PRIOR TO THE INJECTION. SHE HAD NO USUAL ACTIVITY BETWEEN THE INJECTION & THE REACTION. WHEN REP SPOKE WITH THE ACCOUNT, THE PATIENT WAS STILL BEING SEEN IN THE ER AND THEY DID NOT HAVE AN UPDATE."

  Patient problems: Local Reaction

  MAUDE report 8964867 ↗
• InjuryApr 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT IN THE WEEK FOLLOWING A MONOVISC INJECTION, THE PATIENT WAS DIAGNOSED WITH PANCREATITIS. THE PATIENT RECEIVED THEIR INJECTION OF MONOVISC DURING THE WEEK OF MARCH 4, BUT THE SALES REP COULD NOT PROVIDE A SPECIFIC DATE. THE ORIGINAL CASE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SALES REP COULD NOT PROVIDE INFORMATION REGARDING THE LOT NUMBER, THE CURRENT STATUS OF THE PATIENT, OR ANY ADDITIONAL INFORMATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Code Available

  MAUDE report 8470828 ↗
• InjuryApr 1, 2019Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING AN MONOVISC INJECTION, THE PATIENT EXPERIENCED JOINT EFFUSION. THE DAY AFTER THE MONOVISC INJECTION, THE FLUID WAS REMOVED AND THE PATIENT WAS GIVEN A CORTISONE INJECTION. THE SALES REP STATED THAT THIS WAS THE PATIENT'S FIRST INJECTION OF MONOVISC. THE SALES REP DID NOT KNOW WHICH KNEE THE PATIENT RECEIVED THE INJECTION. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE SYRINGE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Code Available

  MAUDE report 8470762 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY AN ETHICON NURSE VIA EMAIL THAT FOLLOWING A MONOVISC INJECTION ON (B)(6) 2018, THE PATIENT DEVELOPED DERMATITIS AND AN ITCHY RASH. THE NURSE STATED THAT HE DEVELOPED THESE SYMPTOMS THE SAME DAY AS THE INJECTION. THE NURSE ALSO STATED THAT HE HAS RECEIVED ROUNDS OF PREDNISONE, WHICH LESSENS HIS SYMPTOMS, BUT THEY WILL RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Rash

  MAUDE report 8277261 ↗
• InjuryJan 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INJECTED WITH MONOVISC RIGHT KNEE AT DR'S OFFICE. LATER THAT DAY, MY KNEE FELT LIKE IT WOULD EXPLODE, WAS SWOLLEN AND EXCRUCIATINGLY PAINFUL. ALMOST WENT TO ET, COULD NOT LAY DOWN, SIT IN CHAIR, WALK, BEND OR STRAIGHTEN KNEE. THIS CONTINUED FOR 2 DAYS AND I RETURNED TO DR. WHO SAID I HAD A REACTION I FOUND OUT THAT AFTER THIS INJECTION YOU ARE NOT TO STAND FOR MORE THAN 1 HOUR WHICH I WAS NOT TOLD BY DR, HE SAID I COULD DO ANYTHING I WANTED. I AM NOW FINALLY ABLE TO BEND AND STRAIGHTEN KNEE WITHOUT TERRIBLE PAIN, THIS LASTED FROM (B)(6) 2018 UNTIL (B)(6) 2018. I COULD NOT DRIVE FOR 3 WEEKS AND WAS CRIPPLED ALL SUMMER AND FALL. BAD DRUG. THERAPY DATE: (B)(6) 2018. REASON FOR USE: OSTEOARTHRITIS OF KNEE.

  Patient problems: Inadequate Pain Relief; Joint Swelling; Pain

  MAUDE report 8236092 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING A MONOVISC INJECTION, THE PATIENT EXPERIENCED JOINT EFFUSION IN THEIR KNEE. THE SALES REP STATED THAT THE FOLLOWING DAY THE FLUID WAS REMOVED FROM THE PATIENT AND THEY WERE GIVEN A CORTISONE INJECTION. THE SALES REP STATED THAT THIS WAS THE PATIENT'S FIRST INJECTION OF MONOVISC. THE SALES REP DID NOT KNOW WHICH KNEE THE PATIENT RECEIVED THE INJECTION. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Joint Swelling

  MAUDE report 8236067 ↗
• InjuryJan 10, 2019Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  DOCTOR HAS PRESCRIBED THE MEDICATION TO BE INJECTED INTO HIP. DATES OF USE (B)(6) 2018; DIAGNOSIS OR REASON FOR USE: M16, 12; IS THE PRODUCT COMPOUNDED? NO; IS THE PRODUCT OVER THE COUNTER? NO.

  Patient problems: No Code Available

  MAUDE report 8236066 ↗
• InjuryJan 10, 2019Off-Label Use; Off-Label Use

  DR IS WANTING TO INJECT MONOVISC INTO THE PT'S SHOULDER. DATES OF USED: (B)(6) 2018 - PRESENT. DIAGNOSIS OR REASON FOR USE: M19.012, M19.011. INJ 88MG/4ML.

  Patient problems: No Code Available

  MAUDE report 8236042 ↗
• InjuryOct 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  "I RECEIVED A CALL FROM (B)(6) ON BEHALF OF HER SON, (B)(6), WHO WAS INJECTED WITH MONOVISC ON (B)(6) 2018 (USA). AROUND (B)(6) 2018, (B)(6) STARTED GETTING "CHRONIC HIVES" (IDIOPATHIC URTICARIA) AND SHE BELIEVES THAT THE HIVES WERE A RESULT OF THE MONOVISC INJECTION. CAN SOMEONE PLEASE FOLLOW UP WITH (B)(6): (B)(6)."

  Patient problems: Irritation

  MAUDE report 7996590 ↗
• InjuryAug 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA EMAIL BY THE SALES REP THAT, AFTER SPEAKING WITH ONE OF THE DOCTORS, SHE WAS INFORMED THAT THERE WAS A PATIENT WHO EXPERIENCED EXTREME PAIN AND SWELLING FOLLOWING A MONOVISC INJECTION. THE SWELLING EXTENDED TO THE ANKLE AND WEIGHT-BEARING ACTIVITY WAS NOT POSSIBLE. THE PATIENT WAS EVENTUALLY SENT TO THE EMERGENCY ROOM AND ADMITTED FOR PAIN MANAGEMENT. ADDITIONAL INFORMATION IS CURRENTLY NOT AVAILABLE DESPITE MULTIPLE REQUESTS.

  Patient problems: Pain; Swelling

  MAUDE report 7810342 ↗
• InjuryFeb 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 1/22/2018 - PATIENT RECEIVED MONOVISC INJECTION IN RIGHT KNEE (B)(6) 2018 - PATIENT CALLED PHYSICIAN OFFICE WITH COMPLAINTS OF EXCRUCIATING PAIN IN RIGHT KNEE. ON (B)(6) 2018 - PATIENT RETURNED TO CLINIC USING WALKER FOR ASSISTANCE. PHYSICIAN DRAINED LARGE AMOUNT OF FLUID FROM RIGHT KNEE. PATIENT FELT IMMEDIATE RELIEF.

  Patient problems: Pain

  MAUDE report 7263219 ↗
• InjuryFeb 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS INJECTED WITH ONE MONOVISC IN THEIR RIGHT KNEE ON (B)(6) 2017, AND 4 DAYS POST-INJECTION THE PATIENT PRESENTED IN THE OFFICE WITH AN EFFUSED KNEE, WHICH HAD TO BE DRAINED. THE PATIENT IS BACK TO NORMAL, BUT BRIAN PETRONE, PA-C WANTED TO MAKE ME AWARE OF THIS ADVERSE EVENT. BRIAN ASKED NOT TO BE CALLED REGARDING THIS CASE BUT I TOLD HIM THAT I HAD TO REPORT IT.

  Patient problems: Synovitis

  MAUDE report 7261297 ↗
• InjuryOct 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SALES REP REPORTED VIA EMAIL PATIENT HAD AN INJECTION OF MONOVISC AND AFTER 2 HOURS RETURNED TO OFFICE NOT FEELING WELL. OFFICE WAS UNABLE TO DIAGNOSE A REACTION AT THIS TIME, BUT LATER IN THE EVENING THE PATIENT WENT TO THE ER AND HAD A CONFIRMED ANAPHYLACTIC REACTION POST-INJECTION.

  Patient problems: No Code Available; Respiratory Distress

  MAUDE report 6912123 ↗