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

Catalog Number 89122-0496-63

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Swelling (2356); Reaction, Injection Site (2442)

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2011, the fda granted the permission for the manufacturer fidia (b)(4).To submit a single mdr for adverse events that involve medical devices manufactured by fidia (b)(4).And imported into the usa by (b)(4).As a consequence, fidia (b)(4).(the manufacturer) is submitting this report even on behalf of (b)(4).(the importer).The present mdr report satisfies the reporting obligations for both companies.The case comes from fidia us and it is related to the product hymovis.The patient after using the product had injection site joint pain, injection site joint movement impairment and injection site joint swelling.The case has been deemed serious due to hospitalization and expected.The causality relationship has been deemed as probable.No new signal alert has been detected.

Event Description

Initial and follow-up information has been processed together.This is a serious, spontaneous adverse event reported to a fidia sales rep involving an (b)(6) male patient.Details of the incident were provided by physician's assistant.This patient had previously received hyalgan injections for osteoarthritis which was well tolerated.On (b)(6) 2017 the patient received a hymovis injection and arthrogram in the right knee, which was well tolerated.On (b)(6) 2017 the patient returned to the clinic and received bilateral hymovis injections, the second in the right knee and first left knee injection, with arthrogram.Again the injections seemed well tolerated.On (b)(6) 2017 the patient returned to the clinic for the final hymovis injection of the left knee with arthrogram and it seemed well tolerated.On an unknown date the patient began to experience increased left knee pain and decreased range of motion.The patient returned to the clinic in a wheelchair on (b)(6) 2017.The left knee pain was described as excruciating.The physician aspirated the left knee removing 35cc of straw colored fluid, injected kenalog and prescribed naprosyn.On (b)(6) 2017 the patient returned to the clinic presenting with left knee pain and swelling.The physician aspirated 10cc of blood tinged fluid.The patient was not taking the naprosyn.The patient again returned to the clinic on (b)(6) 2017.The left knee was swollen and patient was in pain.The physician aspirated 2 cc of straw colored fluid and physician recommended the patient should go to the hospital.The fluid was sent for testing, the results were inconclusive.Between (b)(6) 2017 and (b)(6) 2017 the patient was admitted to hospital.Arthroscopic surgery was performed on the patient's left knee.The knee was washed and debrided of osteophytes.The fluid in the knee was tested and the results were again inconclusive.The patient was given prednisone and doxycycline, and tylenol #3.On (b)(6) 2017 the patient returned to the physician's office for hospital follow-up.The patient was no longer using a wheelchair and on crutches.The patient's knee pain was improving.Patient complained of stomach ache with medications.Experienced a gi bleed, physician's assistant stated the gi bleed was due to medications prescribed, particularly naprosyn.Follow-up information: the adverse event was reviewed by medical affairs who questioned whether the patient had arthrograms, as first reported, or fluoroscopic guided injections.The physician assistant was contact on (b)(6) 2018 who stated that the patient underwent arthrograms.When pressed about whether the patient had arthrograms or fluoroscopic guided injections the pa stated the patient had dye injected into the joint space, images were taken and copied into the patient chart.It could be fluoroscopic images.

• Brand Name: HYMOVIS
• Type of Device: 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
• Manufacturer (Section G): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer Contact: giuseppe di sante ; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031 ; 0498232827
• MDR Report Key: 7245692
• MDR Text Key: 99189852
• Report Number: 9610200-2018-00002
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2018,02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 89122-0496-63
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2018
• Date Report to Manufacturer: 01/11/2018
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR