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

Lot Number 6RSL022ZA

Device Problem Invalid Sensing (2293)

Patient Problems Unspecified Infection (1930); Joint Disorder (2373)

Event Date 04/08/2017

Event Type  Injury  

Event Description

This unsolicited case from (b)(6) was received on 17-may-2017 from a health care professional.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and later after 2 days had serious infection (inflammatory reaction) (joint infection and joint inflammation).No relevant medical history, past drug, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 6rsl022za and expiration date and indication: not provided).On (b)(6) 2017, 2 days after injection, patient experienced significant swelling of the knee.Reportedly the swelling needed to be drained.The same day, 2 days after injection, patient had serious infection (inflammatory reaction).Patient had arthroscopy.Therapy had not been continued and dose was not changed due to event.It was reported that the health care professional (hcp) was alerted by fellow surgeons that there might be a problem with synvisc.It was reported that it took 3 weeks for the swelling to go down.The clinic had quarantined batch 6rsl022za for time being.No further information was available.Consent to contact reporter for follow up was given.Corrective treatment: arthroscopy, needing to be drained for both events.Outcome: recovering for both events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Reporter's causality: probable for both events.Seriousness criteria: medically significant and required intervention for both events.Pharmacovigilance comment: (b)(4) comment dated 19-may-2017: this case concerns a male patient who received treatment with synvisc one and later on had serious infection (inflammatory reaction).The event is temporally related with the device, therefore causality cannot be ruled out completely.Moreover, reporter has also assessed the events as probably related with the synvisc one.However, lack of information regarding patient's underlying condition, medical history and concurrent conditions makes the complete case assessment difficult.

Event Description

This unsolicited case from (b)(6) was received on (b)(6) 2017 from a health care professional.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and later after 2 days had serious infection (inflammatory reaction) (joint infection and joint inflammation).No relevant medical history, past drug, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 6rsl022za and expiration date: may-2019, indication: not provided).On (b)(6) 2017, 2 days after injection, patient experienced significant swelling of the knee.Reportedly the swelling needed to be drained.The same day, 2 days after injection, patient had serious infection (inflammatory reaction).Patient had arthroscopy.Therapy had not been continued and dose was not changed due to event.It was reported that the health care professional (hcp) was alerted by fellow surgeons that there might be a problem with synvisc.It was reported that it took 3 weeks for the swelling to go down.The clinic had quarantined batch 6rsl022za for time being.No further information was available.Consent to contact reporter for follow up was given.Corrective treatment: arhtroscopy, needing to be drained for both events outcome: recovering for both events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 47929.The production and quality control documentation for lot # 6rsl022za expiration date (05/2019) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot 6rsl022za no capa was required.Sanofi 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 has not indicated any safety issue.As of (b)(6) 17, there were a total of 8 complaints on file for lot # 6rsl022z and all related sublots: 3 complaints were on file for lot# 6rsl022z (1) labeling issue (bar code label) and 2 adverse event reports.5 complaints were on file for lot# 6rsl022za: 5 adverse event reports.Sanofi will continue to monitor complaints to determine if a capa is required.Reporter's causality: probable for both events seriousness criteria: medically significant and required intervention for both events follow up was received on (b)(6) 2017.The gptc number was added.Additional information was received on 23-may-2017.Expiry date of synvisc one was added.Ptc results were added and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 23-may-2017: the follow up information received doesnot change previous case assessment.Sanofi company comment dated 19-may-2017: this case concerns a male patient who received treatment with synvisc one and later on had serious infection (inflammatory reaction).The event is temporally related with the device, therefore causality cannot be ruled out completely.Moreover, reporter has also assessed the events as probably related with the synvisc one.However, lack of information regarding the injection technique, patient's underlying condition, medical history, concurrent conditions and concomitant medications makes the complete case assessment difficult.

• Brand Name: SYNVISC ONE (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: 6584470
• MDR Text Key: 75762054
• Report Number: 2246315-2017-00086
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

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: Health Professional
• Device Expiration Date: 05/01/2019
• Device Lot Number: 6RSL022ZA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• 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
• Patient Age: 44 YR