DUROLANE 1082020Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00816986020808), received between May 9, 2016 and Dec 19, 2025 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED A PATIENT EXPERIENCED HIVES, RASH, FAINTING, DIZZINESS, AND INJECTION SITE SWELLING FOLLOWING INTRA-ARTICULAR INJECTION OF DUROLANE.

  Patient problems: Dizziness; Rash; Skin Inflammation/ Irritation; Swelling/ Edema; Syncope/Fainting; Wheal(s)

  MAUDE report 23856108 ↗
• MalfunctionJul 17, 2025Use of Device Problem

  ON [DATE REDACTED] PT RECEIVED A DUROLANE INJECTION TO THE L [LEFT] KNEE IN THE [REDACTED] ORTHOPEDIC OFFICE. NO IMMEDIATE COMPLICATIONS WERE NOTED POST-INJECTION. ON [DATE REDACTED] -- 2 DAYS AFTER INJECTION, THE PT CALLED THE OFFICE REPORTING HE WAS EXPERIENCING SWELLING, INABILITY TO WEIGHT BEAR, AND EXTREME PAIN. PT REPORTED WAS RESTING THE KNEE, USING ICE, ELEVATING THE EXTREMITY, AND TAKING/EXCEEDING THE NORMAL AMOUNT OF ADVIL WITHOUT RELIEF.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 22529904 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTRACTED CELLULITIS AFTER HER DUROLANE INJECTION. PATIENT WAS INITIALLY INJECTED ON (B)(6) 2025 AND IMMEDIATELY EXPERIENCED PAIN, SWELLING, AND BRUISING. ON (B)(6) 2025 PATIENT WAS SEEN BY DR. (B)(6) WHO PRESCRIBED HER CEPHALEXIN 500MG 4 TIMES A DAY FOR 7 DAYS. ON THE SAME DAY THE PATIENT GOES TO EMERGENCY ROOM AND WAS GIVEN TORADOL FOR PAIN AND CEFRIXONE FOR CELLULITIS. PATIENT PROVED POSITIVE FOR GRAM A NEGATIVE BACTERIA (CELLULITIS). PATIENT WAS RELEASED AFTER 7 HOURS. PATIENT IS CURRENTLY TAKING DOXYCYCLINE FOR A TOTAL OF 3 DAYS.

  Patient problems: Bacterial Infection; Bruise/Contusion; Pain; Swelling/ Edema

  MAUDE report 21861597 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT BEING TREATED FOR MODERATE GONARTHROSIS OF THE KNEE WAS INITIALLY INJECTED ON (B)(6) 2025, CONCOMITANTLY WITH DUROLANE AND A STEROID INJECTION. IT WAS REPORTED THE PHYSICIAN USED THE SAME NEEDLE FOR THE DUROLANE INJECTION THAT WAS UTILIZED FOR THE STEROID INJECTION. ONE DAY POST INJECTION, THE PATIENT EXPERIENCED SEVERE PAIN AND SWELLING AND WAS HOSPITALIZED. AN ASPIRATION PROCEDURE WAS COMPLETED AS WELL AS A JOINT PUNCTURE FOR BACTERIAL SAMPLING. THE PATIENT WAS DIAGNOSED WITH SEPTIC ARTHRITIS CAUSED BY STAPHYLOCOCCUS AUREUS. PATIENT WAS PROVIDED ONE INTRAVENOUS AND TWO ORAL ANTIBIOTICS AS WELL AS MORPHINE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025 IN STABLE CONDITION. PATIENT HAS DISCONTINUED MORPHINE AND IS REPORTED TO BE IMPROVING WITH THE USE OF THE ANTIBIOTICS.

  Patient problems: Arthritis; Bacterial Infection; Pain

  MAUDE report 21663766 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS INITIALLY INJECTED ON (B)(6) 2024, CONCOMITANTLY WITH DUROLANE AND A PLATELET-RICH PLASMA (PRP) INJECTION TO THE LEFT KNEE. ONE DAY POST INJECTION THE PATIENT EXPERIENCED; PAIN, SWELLING, FEVER AND REDNESS AT THE INJECTION SITE. THE PATIENT WENT IN FOR A FOLLOW UP VISIT TWO DAYS POST PROCEDURE. DURING THE FOLLOW UP VISIT THE PATIENTS' KNEE WAS ASPIRATED FOR CULTURES. THE CULTURES SHOWED POSITIVE RESULTS FOR INFECTION AND PATIENT WAS DIAGNOSED WITH SEPTIC ARTHRITIS. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 AND UNDERWENT A WASHOUT PROCEDURE. THE PATIENT UPON ADMISSION WAS STARTED ON INTRAVENOUS VANCOMYCIN AND PRIOR TO DISCHARGE THE PATIENT WAS PRESCRIBED DOXYCYCLINE. THE PATIENT WAS DISCHARGED AFTER FOUR DAYS AND THE CURRENT PATIENT STATUS IS RECOVERED AND UNDERGOING PHYSICAL THERAPY.

  Patient problems: Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20578525 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT INJECTED WITH THE DUROLANE PRODUCT EXPERIENCED IMMEDIATE ONSET OF SEVERE PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PER STANDARD PROCEDURE IN CANADA AND RECEIVED MORPHINE FOR PAIN MANAGEMENT. THE PATIENT WAS DIAGNOSED WITH ACUTE SYNOVITIS. THE PATIENT HAD BLOOD DRAWN ON FOUR CONSECTUTIVE DAYS, WITH THE RESULTS SHOWING ELEVATED BLOOD COUNTS THREE TIMES AND RETURNING TO NORMAL LEVELS ON THE FOURTH DRAWN. NO CULTURES WERE TAKEN OF THE AFFECTED AREA, AND NO ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS DISCHARGED AFTER SEVEN DAYS AND HAS A FOLLOW UP APPOINTMENT SCHEDULED WITH THE PHYSICIAN.

  Patient problems: Pain; Synovitis

  MAUDE report 20290540 ↗
• MalfunctionApr 19, 2024

  DUROLANE (HYALURONIC ACID) 60MG/3 ML SYRINGE WAS DEFECTIVE. PROVIDE PULLED CAP OFF AND THE NEEDLE HUB CAME OFF WITH AT THE SAME TIME, SO NEEDLE COULD NOT BE PUT ON THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152354 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PHYSICIAN, A PATIENT INJECTED WITH THE DUROLANE IN THEIR LEFT KNEE, EXPERIENCED RED AND PURPLE RASH ON THE MEDIAL SIDE ONE DAY POST INJECTION. THE PATIENT ALSO REPORTED PAIN AND BLISTERS ON THE MEDIAL LEFT SIDE OF THE KNEE OPPOSITE OF THE INJECTION. THE PATIENT DID GO TO THE EMERGENCY ROOM AND IT IS UNKNOWN IF THERE WAS ANY TREATMENT PROVIDED. THE PATIENT HAD A FOLLOW UP VISIT WITH THE INJECTING PHYSICIAN WHO PRESCRIBED STEROIDS AND ANTIBIOTICS. THE PHYSICIAN INDICATES THE PATIENT HAD NO ADDITIONAL MEDICAL INTERVENTION AND NO CULTURES WERE TAKEN. THREE TO FOUR WEEKS POST INJECTION THE PATIENT IS IMPROVING SIGNIFICANTLY.

  Patient problems: Blister; Pain; Rash

  MAUDE report 18246234 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem

  MEDICATION WAS INJECTED AS DIRECTED. PATIENT EXPERIENCED SEVERE PAIN FOR 4 DAYS FOLLOWING THE INJECTION. DID EVENTUALLY SUBSIDE, BUT AM SEEING THIS HAPPEN IN QUITE A FEW PATIENTS. DIAGNOSIS FOR USE: OSTEOARTHRITIS, PAIN- BILATERAL KNEE.

  Patient problems: Pain

  MAUDE report 13633935 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS HOSPITALIZED AND REQUIRED SURGERY TO TREAT AN INFECTION FOLLOWING A DUROLANE INJECTION. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT DEVELOPED PAIN AND SWELLING. THE PATIENT WAS ADMINISTERED A CORTISONE SHOT WHICH DID NOT ALLEVIATE THE PATIENT'S SYMPTOMS. FOLLOWING THE CORTISONE SHOT THE PHYSICIAN CONFIRMED A SERIOUS INFECTION THAT REQUIRED SURGERY AND A MONTH OF ANTIBIOTICS. THE CURRENT PATIENT STATUS IS UNKNOWN. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN COMPLETED WITH NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 12192280 ↗
• MalfunctionMar 29, 2021Therapeutic or Diagnostic Output Failure

  TWO PTS (ONE MALE, ONE FEMALE) HAD SIMILAR REACTIONS TO DUROLANE VISCOSUPPLEMENTATION INJECTION THAT WERE UNEXPECTED AND UNCOMMON. PATIENT #1 RECEIVED 60 MG SODIUM HYALURONATE INJECTION IN RIGHT KNEE ON (B)(6) 2021. PATIENT RETURNED TO CLINIC ON (B)(6) REPORTING WORSENING PAIN SINCE INJECTION. PATIENT #2 RECEIVED 60 MG SODIUM HYALURONATE INJECTION IN EACH KNEE ALSO ON (B)(6). PATIENT RETURNED TO CLINIC ON (B)(6) WITH 0 MINUTES OF RELIEF SINCE LAST INJECTION AND NO IMPROVEMENT IN SYMPTOMS. APPEARS MEDICATIONS WERE FROM THE SAME LOT. SUSPECT POSSIBLE DEVICE MALFUNCTION DUE TO UNEXPECTED ABSENCE OF RELIEF FROM SYMPTOMS FOR ALL THREE INJECTIONS FROM SAME LOT.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 11588416 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PHYSICIAN ASSISTANT REPORTED AN ADVERSE EVENT IN A FEMALE PATIENT THAT HE INJECTED WITH BILATERAL DUROLANE INJECTIONS FOR OSTEOARTHRITIS IN THE KNEES IN (B)(6) 2020. AN UNKNOWN AMOUNT OF TIME POST-INJECTION, SHE DEVELOPED INJECTION SITE PAIN AND SKIN CHANGES AND/OR DISCOLORATIONS COMMENSURATE WITH NICOLAU SYNDROME. THE PATIENT WAS PROVIDED UNKNOWN TREATMENT, AND HER CURRENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT IS MOST LIKELY RELATED TO A VERY RARE EMBOLIC EVENT FROM THE INTRAARTICULAR CAVITY TO THE SKIN.

  Patient problems: Necrosis

  MAUDE report 10563853 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10 JUNE 2020, THE PHYSICIAN REPORTED AN ADVERSE EVENT IN A FEMALE PATIENT THAT HE INJECTED WITH DUROLANE FOR OSTEOARTHRITIS IN THE KNEE IN (B)(6) 2019. ONE MONTH POST-INJECTION, SHE DEVELOPED SKIN CHANGES AND/OR DISCOLORATIONS COMMENSURATE WITH NICOLAU SYNDROME. A SUBSEQUENT SKIN BIOPSY SHOWED HA PARTICLES IN THE MICROVASCULATURE. THE PATIENT WAS SUCCESSFULLY TREATED WITH HYALURONIDASE IN THE DERMATOLOGY DEPARTMENT. ALL SKIN DISCOLORATIONS DISAPPEARED WITHOUT FURTHER PROBLEMS. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT IS MOST LIKELY RELATED TO A VERY RARE EMBOLIC EVENT FROM THE INTRA-ARTICULAR CAVITY TO THE SKIN.

  Patient problems: Necrosis

  MAUDE report 10242179 ↗
• InjuryMay 8, 2020Patient-Device Incompatibility

  MEDWATCH MW5093268 RECEIVED 09 MAR 2020: SERIOUS INJURY, REQUIRED INTERVENTION, "ONE MONTH AFTER LEFT KNEE DUROLANE INJECTION, PATIENT DEVELOPED SKIN RASH DEEMED TO BE CAUSED BY SKIN EMBOLUS FROM HYALURONIC ACID CRYSTALS."

  Patient problems: Rash

  MAUDE report 10040464 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS A (B)(6) YEAR OLD MALE AND HE WAS INJECTED ON (B)(6) 2019 USING IMAGE GUIDANCE. HE WAS INJECTED SUPERIOR LATERALLY WHILE IN A LYING POSITION. THE PATIENT STARTED EXPERIENCING PAIN ALMOST IMMEDIATELY AS HE WAS DRIVING HOME FROM HAVING THE INJECTION. HE FELT THE PAIN ARTERIAL MEDIALLY, NEAR PROXIMAL TIBIAL - OPPOSITE TO THE INJECTION SITE. PATIENT DEVELOPED A MOTTLED, RED/PURPLE SKIN ABNORMALITY THAT HAS PROGRESSED TO COVER A 5X3 INCH AREA AT THE KNEE WITH ONGOING PAIN. PHYSICIAN SUSPECTED POSSIBLE SKIN NECROSIS. THE PATIENT HAS A HISTORY OF SIGNIFICANT TIBIAL CYSTS AND A RECENT MRI POST DUROLANE INJECTION SHOWED THAT ONE OF THE CYSTS LOOKS TO BE "LEAKING INTO THE SOFT TISSUE ANTERIORLY". TREATMENT HAS INCLUDED DAILY HYPERBARIC TREATMENT, NITROGLYCERIN, TOPICAL TREATMENTS (ARE TREATING LIKE A CHEMICAL BURN). THE PATIENT HAS BEEN SEEN BY DERMATOLOGY AND VASCULAR SPECIALISTS. PATIENT HAS SINCE SHOWN SIGNS OF IMPROVEMENT.

  Patient problems: Necrosis

  MAUDE report 8739461 ↗
• InjuryMay 9, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE DOCTOR THAT ECTOPIC OSSIFICATION EMERGED AFTER START OF THERAPY IN THE TREATMENT AREA FOR APPROXIMATELY TWO WEEKS. THE CAUSAL OPINION IS DEEMED POSSIBLY RELATED BECAUSE THE CALLUS IS MADE AND CAUSATION CANNOT BE DENIED COMPLETELY. THE PATIENT HAS STOPPED USING THE DEVICE AND ETIDRONATE DISODIUM IS BEING ADMINISTERED. ATTEMPTS FOR ADDITIONAL FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL UP TO DATE.

  Patient problems: Extraskeletal ossification

  MAUDE report 5640824 ↗