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

Lot Number 7RSL021, 7RSL022

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Bacterial Infection (1735); Arthralgia (2355); Joint Swelling (2356)

Event Date 12/07/2017

Event Type  malfunction  

Event Description

Based on additional information received on 23-feb-2018 from health care professional, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added.This case is cross referred with the (b)(4) (cluster).This unsolicited case from united states was received on 28-dec-2017 from health care professional.This case concerns a female patient (age not provided) who received treatment with synvisc one injection and after 1 day left knee red, left knee hot, left knee pain/left knee tender, anterior portion of left knee continued to become more swollen and after 2 days, had infections/ methylobacterium species in sterile body fluid culture.Also device malfunction was identified for the reported lot number.No past drug, concomitant medication and concurrent condition was provided.The concomitant medications included lidocaine (local anesthetic).On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection (batch/lot number: 7rsl021 and 7rsl022; expiration date: may-2020 for both) (bilateral knee joint injections) at a dose of 6 ml once for knee pain.On (b)(6) 2017, (latency 1 day), the patient had left knee pain that began in the left posterior region and had spread to the superior portion of left calf.The same day, the anterior portion of left knee continued to become more swollen, red, hot and tender at night.The patient was advised to come to ed (arthroscopic irrigation and debridement on second ed visit with admission).On (b)(6) 2017, sterile body fluid culture aerobic was abnormal (methylobacterium spp).On an unknown date, after unknown latency, patient had infections.Corrective treatment: arthroscopic irrigation and debridement for left knee red, left knee hot, left knee pain/left knee tender and anterior portion of left knee continued to become more swollen outcome: unknown for have infections and have infections/ methylobacterium species in sterile body fluid culture; recovered for rest of the events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for have infections/ methylobacterium species in sterile body fluid culture; required intervention for device malfunction, left knee red, left knee hot, left knee pain/left knee tender and anterior portion of left knee continued to become more swollen additional information was received on 23-feb-2018 from health care professional.This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added.The event term was updated from infections to have infections/ methylobacterium species in sterile body fluid culture (ime).The suspect product batch/lot number, expiry date, dose, frequency and indication were added.The additional events of left knee red, hot, tender, left knee pain, left knee pain that began in the left posterior region and has spread to the superior portion of left calf and left knee swollen were added with details.The patient's concomitant medication was added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 28-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced methylobacterium infection, joint warmth,injection site joint redness and knee swelling.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

Event Description

Based on additional information received on 23-feb-2018 from health care professional, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added.This case is cross referred with the case (b)(4) (cluster).This unsolicited case from united states was received on 28-dec-2017 from health care professional.This case concerns a female patient (age not provided) who received treatment with synvisc one injection and after after 1 day left knee red, left knee hot, left knee pain/left knee tender, anterior portion of left knee continued to become more swollen and after 2 days, had infections/ methylobacterium species in sterile body fluid culture.Also device malfunction was identified for the reported lot number.No past drug, concomitant medication and concurrent condition was provided.The concomitant medications included lidocaine (local anesthetic).On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection (batch/lot number: 7rsl021 and 7rsl022; expiration date: may-2020 for both) (bilateral knee joint injections) at a dose of 6 ml once for knee pain.On(b)(6) 2017, (latency 1 day), the patient had left knee pain that began in the left posterior region and had spread to the superior portion of left calf.The same day, the anterior portion of left knee continued to become more swollen, red, hot and tender at night.The patient was advised to come to ed (arthroscopic irrigation and debridement on second ed visit with admission).On (b)(6) 2017, sterile body fluid culture aerobic was abnormal (methylobacterium spp).On an unknown date, after unknown latency, patient had infections.Corrective treatment: arthroscopic irrigation and debridement for left knee red, left knee hot, left knee pain/left knee tender and anterior portion of left knee continued to become more swollen outcome: unknown for have infections and have infections/ methylobacterium species in sterile body fluid culture; recovered for rest of the events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.For lot number: 7rsl022 the production and quality control documentation for lot # 7rsl022 expiration date (05/2020) 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 # 7rsl022 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 (b)(6) 2018, there were 18 complaints on file for lot # 7rsl022: (17) adverse event reports and (1) leaky syringe.Sanofi would continue to monitor complaints to determine if a capa was required.Seriousness criteria: important medical event for have infections/ methylobacterium species in sterile body fluid culture; required intervention for device malfunction, left knee red, left knee hot, left knee pain/left knee tender and anterior portion of left knee continued to become more swollen additional information was received on (b)(6) 2018 from health care professional.This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added.The event term was updated from infections to have infections/ methylobacterium species in sterile body fluid culture (ime).The suspect product batch/lot number, expiry date, dose, frequency and indication were added.The additional events of left knee red, hot, tender, left knee pain, left knee pain that began in the left posterior region and has spread to the superior portion of left calf and left knee swollen were added with details.The patient's concomitant medication was added.Clinical course updated.Text was amended accordingly.Additional information was received on 13-mar-2018 and 14-mar-2018 (all the information processed together with clock start date of 13-mar-2018).Investigation summary added for lot number: 7rsl022.Text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 28-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced methylobacterium infection ,joint warmth,injection site joint redness and knee swelling.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

• 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: 7331169
• MDR Text Key: 102350101
• Report Number: 2246315-2018-00369
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7RSL021, 7RSL022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 03/25/2018
• Patient Sequence Number: 1
• Treatment: LIDOCAINE(CON.)START; LIDOCAINE(CON.)START; LIDOCAINE(CON.)STOP; LIDOCAINE(CON.)STOP
• Patient Outcome(s): Other; Required Intervention