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

Lot Number T1404

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Inflammation (1932); Sepsis (2067); Reaction (2414); Test Result (2695)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Based on additional information received on 07/01/2015, this case initially considered as non-serious has been upgraded to serious as serious events of septic arthritis and development of s.Viridans have been added.This unsolicited device case from (b)(6) was received on (b)(6) 2015 from a physician (orthopaedist).This case involved a male patient of unknown age who received treatment with synvisc one and developed septic arthritis and streptococcus viridans (s.Viridans).No past drugs, medical history, concomitant medication or concurrent condition was reported.It was reported that in 2013, patient received 6 infiltrations of synvisc classic, performed in outpatient setting and did not present any complications.On (b)(6) 2015, the patient received treatment with intra-articular synvisc one injection at a dose of 6ml, once (batch/lot number: t1404 and expiration date: not provided) into left knee for gonarthrosis.On an unknown date in (b)(6) 2015, on first 24 hours, patient presented intense acute inflammatory response, without improvement after using unspecified analgesics, anti-inflammatories and cryotherapy.It was reported that in the following days, patient presented progressive worsening, fever, joint leakage and joint block.On an unknown date in (b)(6) 2015, laboratorial analysis of joint liquid showed development of s.Viridans and it was confirmed diagnosis of septic arthritis.Reportedly, the patient was still hospitalized and was administered unspecified antibiotics via intravenous.Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criteria: in patient/prolonged hospitalization and required intervention (intravenous antibiotics) for both the events.Additional information was received on 07/01/2015 from a physician.The event of unspecified adverse event was deleted.The serious events of septic arthritis and development of s.Viridans along with their details were added and the case was updated to serious from non-serious with seriousness criteria of inpatient or prolonged hospitalization and required intervention.The patient's laboratory tests along with their results were added.The therapy start date, frequency, knee side, indication and batch/lot number of synvisc one was added.The patient's clinical course was updated and the text was amended accordingly.

Manufacturer Narrative

Pharmacovigilance comment: sanofi company comment dated 07/07/2015: this case concerns a male patient who was hospitalized with septic arthritis and s.Viridans infection after treatment with synvisc one.The events are temporally related to the device, therefore causality of synvisc one cannot be ruled out completely.However the maintenance of aseptic conditions is mandatory during the injection of the product and any deviation from the same could provide a plausible explanation for the event.

Manufacturer Narrative

The production and quality control documentation for lot # t1404, with expiration date (06/2017) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review and lot # frequency analysis for lot # t1404, no capa was required.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.As of (b)(6) 2015, this was the only complaint reported for lot # t1404: (1) adverse event report.Genzyme biosurgery would continue to monitor complaints as stated in product complaint handling to determine if a capa was required.Seriousness criteria: in patient/ prolonged hospitalization and required intervention (intravenous antibiotics) for both the events.Additional information was received on (b)(6) 2015.The expiration date of the suspect product was added.Global ptc number with results was added and the text was amended accordingly.Pharmacovigilance comment: sanofi company follow up comment dated (b)(6) 2015: follow up information received, does not change previous case assessment.

• Brand Name: SYNVISC ONE (SYNVISC ONE)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corporate drive., ms: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4908226
• MDR Text Key: 6832509
• Report Number: 2246315-2015-96139
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Type of Report: Initial,Followup
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: T1404
• Date Manufacturer Received: 06/30/2015
• 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
• Treatment: PREV MEDS = UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 62