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

Lot Number 7RSL031ZA

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

Patient Problem Bacterial Infection (1735)

Event Date 03/09/2018

Event Type  Injury  

Event Description

This unsolicited case from united states was received on (b)(6) 2018 and (b)(6) 2018 (processed together with clock start date of (b)(6) 2018) from a healthcare professional.This case involves a (b)(6) year old male patient who received treatment with synvisc one and 01 day later had joint fluid culture gram positive.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On (b)(6) 2018, the patient ini-received tiated treatment intra-articular synvisc one, injection, at a dose of 6 ml, once (batch/lot number: 7rsl031za) for osteoarthritis knee and pain knee.On (b)(6), 01 day after receiving treatment with synvisc one, the patient had pain at noon.Patient went to the er (emergency room) due to severe pain and swelling and a feverish feeling.Patient did have a fever upon admission to the er.Er aspirated the knee.There was a significant amount of pussy fluid which was sent to the lab to check cell count and gram stain.Gram stain was negative.White blood cell count of joint fluid was 1.6 million.Inflammatory markers were extremely high and his wbc was 20.Patient was admitted from the er for observation with iv antibiotics and iv nsaids.He was observed for 24 hours and the culture then came back gram positive.On (b)(6)2018, the patient then underwent an arthroscopic debridement and lavage where frank pus was drained.On (b)(6) 2018, wbc was 13.6.At the time of reported on (b)(6) 2018, patient was still in the hospital undergoing observation.Final culture and sensitivity was pending.Id was also evaluating patient.Corrective treatment: iv antibiotics,iv nsaids, arthroscopic debridement and lavage outcome: unknown seriousness criteria: hospitalization or prolongation and required intervention pharmacovigilance comment: sanofi company comment dated (b)(6) 2018.This case concerns a patient who presented arthritis bacterial after receiving treatment with synvisc.Based upon the information, a significant temporal relationship can be established, so the causal role of the product cannot be denied with the occurrence of event.However, further detailed information regarding detailed medical history, lab data, concurrent conditions, concomitant medications and other risk factors would aid in the better assessment of the case.

Event Description

This unsolicited case from united states was received on (b)(6) 2018 and (b)(6) 2018 (processed together with clock start date of (b)(6) 2018 from a healthcare professional.This case involves a 39 year old male patient who received treatment with synvisc one and 01 day later had joint fluid culture gram positive.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On (b)(6) 2018, the patient inireceivedtiated treatment intra-articular synvisc one, injection, at a dose of 6 ml, once (batch/lot number: 7rsl031za) for osteoarthritis knee and pain knee.On (b)(6) 208, 01 day after receiving treatment with synvisc one, the patient had pain at noon.Patient went to the er (emergency room) due to severe pain and swelling and a feverish feeling.Patient did have a fever upon admission to the er.Er aspirated the knee.There was a significant amount of pussy fluid which was sent to the lab to check cell count and gram stain.Gram stain was negative.White blood cell count of joint fluid was 1.6 million.Inflammatory markers were extremely high and his wbc was 20.Patient was admitted from the er for observation with iv antibiotics and iv nsaids.He was observed for 24 hours and the culture then came back gram positive.On (b)(6) 2018, the patient then underwent an arthroscopic debridement and lavage where frank pus was drained.On (b)(6) 2018, wbc was 13.6.At the time of reported on (b)(6) 2018, patient was still in the hospital undergoing observation.Final culture and sensitivity was pending.Id was also evaluating patient.Corrective treatment: iv antibiotics,iv nsaids, arthroscopic debridement and lavage outcome: unknown.Seriousness criteria: hospitalization or prolongation and required intervention a product technical compliant (ptc) was initiated with global ptc number: 53108.The production and quality control documentation for lot # 7rsl031z expiration date (2020-09-30) 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 # 7rsl031z no capa was required.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.As of 28-mar-18 there was only 1 complaint on file for lot # 7rsl031z and all related sublots.1 complaint was on file for lot# 7rsl031za: adverse event report.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product complaint handling" to determine if a capa was required.Additional information was received on 28-mar-2018.Investigation summary and gptc number was added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 28-mar-2018.Follow up information received, does not change previous case assessment.This case concerns a patient who presented arthritis bacterial after receiving treatment with synvisc.Based upon the information, a significant temporal relationship can be established, so the causal role of the product cannot be denied with the occurrence of event.However, further detailed information regarding detailed medical history, lab data, concurrent conditions, concomitant medications and other risk factors would aid in the better 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
• MDR Report Key: 7387912
• MDR Text Key: 104026712
• Report Number: 2246315-2018-00413
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Lot Number: 7RSL031ZA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR