MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYMOVIS; HIGH MOLECULAR WEIGHT VISCOELASTIC HYALURONAN

Catalog Number	89122049601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Fever (1858); Arthralgia (2355); Ambulation or Postural Difficulties (2544); Injection Site Reaction (4562); Injection Site Pooling (4840)
Type of Reportable Event	Serious Injury
Event or Problem Description
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patient has been treated with hymovis (batch no.H48960; exp.21.Nov.2028) for unknown indication.The suspect product was withdrawn with positive dechallenge.On unknown date of (b)(6) 2025, the patient experienced: pseudogout, injection site joint erythema, injection site joint swelling,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 in and recommended 4 weeks of daptomycin and ceftriaxone.A picc line was placed to facilitate the subacute administration of antibiotics.Patient worked with physical therapy and was able to ambulate prior to discharge.The outcome of the events was reported to be recovering/resolving.Reactions as reported by the primary source: "the patient received her first bilateral hymovis injections on (b)(6) 2025.She returned to the clinic on (b)(6) 2025 for her second bilateral hymovis injections.The patient had swelling, severe pain of the right knee, a low-grade fever and was not feeling well.The patient was advised to go to the emergency room for possible washout of the right knee.The patient was admitted to the emergency department on (b)(6) 2025 at 2300 hrs.The patient was admitted under the assumption of septic arthritis based on symptoms of low-grade fever, sudden erythematous, tender, non-weightbearing, swollen right knee.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 40ml purulent fluid and white blood cells of 109,150.Radiographs of the knee showed moderate tricompartmental osteoarthritic changes with joint space narrowing and osteophyte formation in his small effusion.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 in and recommended 4 weeks of daptomycin and ceftriaxone.A picc line was placed to facilitate the subacute administration of antibiotics.Patient worked with physical therapy and was able to ambulate prior to discharge.Patient was otherwise medically optimally treated in the postoperative period, uncomplicated hospital course.Patient was discharged from the hospital on (b)(6) 2025.On (b)(6) 2025 lab results indicated no bacterial growth but positive for pseudogout".The reactions were deemed serious since the patient was hospitalized from (b)(6) 2025.This is a duplicate case submitted by fidia pharma usa inc as the initial importer for fidia farmaceutici spa, the manufacturer.Manufacturer's mdr # 9610200-2025-00004.

• Brand Name: HYMOVIS
• Common Device Name: HIGH MOLECULAR WEIGHT VISCOELASTIC HYALURONAN
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica; 3/a; abano terme,, padua 35031 ; IT 35031
• MDR Report Key: 22346535
• Report Number: 3009107511-2025-00001
• Device Sequence Number: 20962239
• Product Code: MOZ
• UDI-Device Identifier: M71389122496630A16
• UDI-Public: M71389122496630A16
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/27/2025
• Report Date (Section F): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 89122049601
• Device Lot Number: H48960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIMVASTATINSYNTHROID (LEVOTHYROXINE SODIUM)RESTA; SIMVASTATINSYNTHROID (LEVOTHYROXINE SODIUM)RESTA
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/28/2025