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

Lot Number UNKNOWN

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

Patient Problem Inflammation (1932)

Event Date 10/30/2016

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on 02-dec-2016 from a physician.This case involves a (b)(6) male patient who started treatment with synvisc and 16 days after starting treatment experienced pseudoseptic reaction.The patient's previous medication, medical history, concomitant medications and concurrent conditions were not reported.On (b)(6) 2016, the patient received treatment with intra-articular synvisc injection, weekly (dose, batch/ lot number, expiration date: not reported) in the knee for osteoarthritis.The patient received the last dose on (b)(6) 2016.On (b)(6) 2016, 16 days after starting treatment, the patient experienced pseudoseptic reaction and had hot painful and swollen knee.The patient had arthroscopic debridement.Outcome: not recovered.A pharmaceutical technical complaint (ptc) initiated and results were pending for the same.Seriousness criteria: required intervention.

Event Description

This unsolicited device case from united states was received on 02-dec-2016 from a physician.This case involves a (b)(6) male patient who started treatment with synvisc and 16 days after starting treatment experienced pseudoseptic reaction.The patient's previous medication, medical history, concomitant medications and concurrent conditions were not reported.On (b)(6) 2016, the patient received treatment with intra-articular synvisc injection, weekly (dose, batch/ lot number, expiration date: not reported) in the knee for osteoarthritis.The patient received the last dose on (b)(6) 2016.On (b)(6) 2016, 16 days after starting treatment, the patient experienced pseudoseptic reaction and had hot painful and swollen knee.The patient had arthroscopic debridement.Corrective treatment: arthroscopic débridement.Outcome: not recovered.A pharmaceutical technical complaint (ptc) was initiated with (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: required intervention additional information was received on 19-dec-2016.Global ptc number and ptc results were added.Text was amended accordingly.

• Brand Name: SYNVISC
• 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: 6181500
• MDR Text Key: 62599202
• Report Number: 2246315-2016-00183
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 134