MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Arthralgia (2355); Joint Swelling (2356)

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 28-feb-2018 from a non-healthcare professional.This case concerns an adult female patient who received treatment with synvisc one and later after unknown latency had major swelling in injected knee/ leg, major swelling in injected knee/ leg and blood clot in injected knee/leg.No past drug, concomitant medication or concurrent condition was provided.The medical history included clotting disorder.On an unknown date, (within last couple of months) the patient initiated treatment with intra-articular synvisc one injection (dose, frequency, indication, batch/lot number and expiry date: unknown) into one unspecified knee.On an unknown date, after unknown latency, the patient was tested positive for a blood clotting disorder.On an unknown date, after unknown latency the patient had blood clot with major swelling and excruciating pain in the injected knee/leg.It was reported that the nurse injected steroid to help and patient was doing well.It was reported that the patient had clotting disorder prior starting treatment with synvisc one and she did not suspect that this problem is product related.Corrective treatment: not reported for blood clot in injected knee/leg; steroids for rest of the events outcome: recovering for all the events a global pharmaceutical technical complaint was initiated with (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Seriousness criteria: important medical event for blood clot in injected knee/leg; required intervention for rest of the events additional information was received on 05-mar-2018.Gptc number and ptc results were added.Pharmacovigilance comment: sanofi company comment follow up dated 05-mar-2018: the follow up information does not change the prior assessment of the case.This case concerns a female patient who received synvisc one injection and later experienced a blood clot with "major swelling and excruciating pain" in the injected knee/leg.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the site and technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, any past or concomitant medications and other risk factors would aid in the complete medical assessment of the case.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7348407
• MDR Text Key: 102756902
• Report Number: 2246315-2018-00401
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• 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: 02/28/2018

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
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention