MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYMOVIS; INTRA-ARTICULAR INJECTION

Catalog Number 89122-0496-63

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Joint Swelling (2356); Joint Disorder (2373)

Event Date 07/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The case came from an (b)(6) consumer through phone call who after using the product hymovis had: injection site joint pain, injection site joint swelling, injection site joint effusion and femur fracture.The case has been deemed as serious due to hospitalization and important medical event caused by the reaction femur fracture.The case has been deemed serious/unexpected due to the reaction femur fracture not listed in the patient package leaflet.The causality relationship has been deemed as probable for the reactions injection site joint, injection site joint swelling and injection site joint effusion.The reaction femur fracture has been deemed as remote due to a not reasonable temporal sequence (20 days after the administration of the product and 5 days after the resolution of the previous symptoms).Moreover, the femur fracture can be explained by the clinical history of the patient who had already the femur fracture of the other leg.It can suggest a osteoporotic disease.The case is conservatively deemed as serious and reported to (b)(6) and fda.No new signal alert has been detected.

Event Description

This was a spontaneous report from a consumer (the interlocutor authorized personal data processing).The interlocutor, a (b)(6) female patient, called to report that, on (b)(6) 2017, she bought two vials of hymovis 24 mg/3 ml gel for injection (hyaluronate sodium hexadecylamine) from fidia, to treat an inflammation of right knee affected of gonarthrosis, on indication of her orthopedic (dr.(b)(6)) of (b)(6) hospital in (b)(6).The same pathology is also present in the left knee that was not treated.On (b)(6) 2017 the orthopedic administered hymovis 24 mg/3 ml gel for injection (hyaluronate sodium hexadecylamine), by intra-articular route, at the dosage of 1 vial, in the right knee.Immediately the patient experienced a very strong pain and then, on the following days, she experienced injection site joint swelling and effusion.To treat the events, the patient underwent to arthrocentesis, ultrasound, treatment with artrosilene (ketoprofen lysine) and teca therapy.On (b)(6) 2017 the symptomatology was resolved.On (b)(6) 2017, while she was walking in the garden, the patient fell because "her knee did not support her" and she experienced fracture of right femur.The patient was hospitalized in (b)(6) hospital in (b)(6) where the fracture was reduced and she underwent to syntesis with endomidollar nail after antibiotic and antithrombotic prophylaxis.In the past the patient has already experienced fracture of left femur.At the time of the reporting the patient was convalescent, recovering from the event.

Manufacturer Narrative

Exemption number e2011017.(b)(4).The case came from an (b)(6) consumer through phone call who after using the product hymovis had: injection site joint pain, injection site joint swelling, injection site joint effusion and femur fracture.The case has been deemed as serious due to hospitalization and important medical event caused by the reaction femur fracture.The case has been deemed serious/unexpected due to the reaction femur fracture not listed in the patient package leaflet.The causality relationship has been deemed as probable for the reactions injection site joint, injection site joint swelling and injection site joint effusion.The reaction femur fracture has been deemed as remote due to a not reasonable temporal sequence (20 days after the administration of the product and 5 days after the resolution of the previous symptoms).Moreover, the femur fracture can be explained by the clinical history of the patient who had already the femor fracture of the other leg.It can suggest a osteoporotic disease.The case is conservatively deemed as serious and reported to italian moh and fda.No new signal alert has been detected.Follow-up information: the batch number involved in the aes is a05720.A deep evaluation of production and quality control documentation was performed by fidia's quality assurance department.From this evaluation no anomaly was found.One syringe of hymovis batch number a05720 was received in the intact blister, as the claimed sample, on which the bacterial endotoxin content test was performed.The test result conforms to the acceptance criteria.On the basis of the verifications performed, a qualitative problem is excluded in the batch involved in the aes.

Event Description

This was a spontaneous report from a consumer (the interlocutor authorized personal data processing).The interlocutor, a (b)(6) year-old female patient, called to report that, on (b)(6) 2017, she bought two vials of hymovis 24mg/3ml gel for injection (hyaluronate sodium hexadecylamide) from fidia, to treat an inflammation of right knee affected of gonarthrosis, on indication of her orthopedic (dr.(b)(6)) of (b)(6) hospital in (b)(6).The same pathology is also present in the left knee that was not treated.On (b)(6) 2017 the orthopedic administered hymovis 24mg/3ml gel for injection (hyaluronate sodium hexadecylamide), by intra-articular route, at the dosage of 1 vial, in the right knee.Immediately the patient experienced a very strong pain and then, on the following days, she experienced injection site joint swelling and effusion.To treat the events, the patient underwent to arthrocentesis, ultrasound, treatment with artrosilene (ketoprofen lysine) and teca therapy.On (b)(6) 2017 the symptomatology was resolved.On (b)(6) 2017, while she was walking in the garden, the patient fell because "her knee did not supported her" and she experienced fracture of right femur.The patient was hospitalized in cisanello hospital in pisa where the fracture was reduced and she underwent to syntesis with endomidollar nail after antibiotic and antithrombotic prophylaxis.In the past the patient has already experienced fracture of left femur.At the time of the reporting the patient was convalescent, recovering from the event.

• Brand Name: HYMOVIS
• Type of Device: INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3a; 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 ; 8232827
• MDR Report Key: 6885702
• MDR Text Key: 87218791
• Report Number: 9610200-2017-00007
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 89122-0496-63
• Device Lot Number: A05720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2017
• Event Location: Home
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 75 YR