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

Device Problem Insufficient Information (3190)

Patient Problems Reaction, Injection Site (2442); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).From the initial information received on 2 october 2015 no seriousness criteria came to light.On the basis of the follow-up information received on 10 october 2015 a second adverse drug reaction, knee infection, has been reported by consumer.This reaction has been deemed as being serious from a medical point of view, due to the concomitant hospitalization of the patient for an arthroscopic surgery.Thus, the case has been upgraded to "serious".We are unable to perform a deep evaluation of the causal relationship, due to the poor information.It is unclear if the infection of the knee was a consequence of the arthroscopic surgey or due to the hyalgan administration.However, a conservative approach suggested to consider the case as being serious.The case is notified late due to the technical problems during the test phase for the electronic submission as webtrader.The case reports initial and follow-up information.Device is not available.

Event Description

This spontaneous, non-serious adverse event was reported by a (b)(6) old male consumer.On an unknown date three weeks ago the patient began weekly injections of hyalgan for osteoarthritis.The patient reported that after he had 2 injections in his right knee and 3 injections in his left knee, he experienced stiffness in both knee joints.The patient reported that he got temporary relief from icing his knees.The patient reported that the stiffness in his knee joints was not getting better or worse and he will have his third injection in his right knee next week.The lot number and expiration date are unknown.As of (b)(6) 2015 the patient continued on hyalgan and continued to experience knee stiffness.The reporter did not provide a causality statement.Follow-up received on 10/nov/2015: patient stated that the stiffness in his left knee has improved; however, the stiffness in his right knee has worsened due to an unknown infection.The patient underwent arthroscopic surgery to his right knee in the middle of (b)(6) 2015 which happened to be about the same time as his 3rd injection into his right knee.As of (b)(6) 2015 the patient discontinued hyalgan and is being treated with unknown antibiotics for the infection.Patient reported he was unable to determine the cause of the infection.Follow-up received on 30/nov/2015: consumer reported that stiffness in his left knee has resolved and that the infection in his right knee has improved with antibiotics with marginal improvement of stiffness.Follow-up received on 21/dec/2015: patient stated that his bloodwork came back fine and everything is fine with his right knee.

• Brand Name: HYALGAN
• 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, 3a; abano terme, padua 35031 ; IT 35031
• Manufacturer Contact: giuseppe di sante ; via ponte della fabbrica, 3a; abano terme, padua 35031 ; IT 35031 ; 8232827
• MDR Report Key: 5506530
• MDR Text Key: 40534362
• Report Number: 9610200-2015-00005
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2015,03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2015
• Date Manufacturer Received: 11/10/2015
• 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
• Treatment: IBUPROFEN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR
• Patient Weight: 86