Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe 89122-4966-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M71389122496630A16), received between Jun 27, 2025 and Jun 27, 2025 — classified as 2 injuries.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A DUPLICATE CASE SUBMITTED BY FIDIA PHARMA USA INC AS THE INITIAL IMPORTER FOR FIDIA FARMACEUTICI SPA, THE MANUFACTURER. MANUFACTURER'S MDR #9610200-2025-00005 REACTIONS AS REPORTED BY THE PRIMARY SOURCE: "THE PATIENT HER FIRST BILATERAL INJECTIONS OF HYMOVIS ON (B)(6) 2025. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2025 AND RECEIVED HER SECOND INJECTION IN THE RIGHT KNEE. PATIENT EXPERIENCED CHEST PAIN, SHORTNESS OF BREATH AND DIZZINESS AFTER RECEIVING THE INJECTION. THE HCP DID NOT ADMINISTER THE SECOND INJECTION IN HER LEFT KNEE DUE TO THE REACTION AFTER RECEIVING THE INJECTION IN THE RIGHT KNEE. THE PATIENT WAS ADVISED TO GO TO THE EMERGENCY ROOM (ER) DUE TO CHEST PAIN AND RIGHT KNEE PAIN POST INJECTION." THE CHEST PAIN, SHORTNESS OF BREATH AND DIZZINESS WERE ORIGINALLY ATTRIBUTED BY THE REPORTER TO THE RIGHT KNEE PAIN THE PATIENT EXPERIENCED AFTER RECEIVING THE INJECTION. "THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2025 AT 1709 HOURS FOR OBSERVATION. THE PATIENT REPORTED AN INCREASING DENSE SHARP CHEST PAIN WITHOUT EPISODE OF DIZZINESS, LIGHTHEADED, NAUSEA OR RADIATING PAIN. EKG PERFORMED, WHICH WAS NEGATIVE FOR ISCHEMIA AND TROPONIN WERE FLAT. P

  Patient problems: Arthralgia; Chest Pain; Dizziness; Dyspnea; Joint effusion

  MAUDE report 22349898 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 73-YEAR-OLD FEMALE PATIENT HAS BEEN TREATED WITH HYMOVIS (BATCH NO. H48960; EXP. 21.NOV.2028) FOR UNKNOWN INDICATION. THE SUSPECT PRODUCT WAS WITHDRAWN WITH POSITIVE DECHALLENGE. ON UNKNOWN DATE OF (B)(6) 2025, THE PATIENT EXPERIENCED: PSEUDOGOUT, INJECTION SITE JOINT ERYTHEMA, INJECTION SITE JOINT SWELLING, INJECTION SITE JOINT TENDERNESS, LOW GRADE FEVER, GAIT INABILITY. ACCORDING TO THE REPORTER THE EVENTS CAUSED/PROLONGED HOSPITALIZATION. ACTIONS TAKEN TO TREAT THE EVENTS: THE EMERGENCY DEPARTMENT DECIDED TO TAP THE KNEE UNDER ULTRASOUND GUIDANCE. ASPIRATE WAS BLOOD TINGED SEROUS, MINIMAL FLUID DRAINAGE WAS ASPIRATED. THE PATIENT WAS PLACED ON BROAD SPECTRUM ANTIBIOTICS AND PLACED NPO AT MIDNIGHT TO PREPARE FOR ORTHOPEDIC INTERVENTION ON (B)(6) 2025. THE ASPIRATION RESULTED IN 141,000 WHITE BLOOD CELLS. THE ORTHOPEDIC DEPARTMENT REPEATED THE ASPIRATION RESULTING 40 ML PURULENT FLUID AND WHITE BLOOD CELLS OF 109,150. THE PATIENT HAD ARTHROTOMY OF THE RIGHT KNEE WITH EXPIRATION DRAINAGE WHICH IS THE SAME TREATMENT AND PROTOCOL FOR POSSIBLE SEPTIC ARTHRITIS ON (B)(6) 2025. PATIENT WAS MAINTAINED ON BROAD-SPECTRUM ANTIBIOTICS. INFECTIOUS DISEASE DEPARTMENT WEIGHED

  Patient problems: Administration Site Reaction; Administration Site Swelling; Ambulation or Postural Difficulties; Arthralgia; Arthritis; Fever

  MAUDE report 22346535 ↗