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

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problem Arthritis (1723)

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(6) 2018 from a nurse.This case involves a male patient of unknown age who received treatment with synvisc one and later after 8 hours had left knee pain/ stabbing pain/growth of a gram-negative bacillus was detected from the synovial fluid culture collected.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the initiated treatment with intra-articular synvisc one injection (ultrasound guided injection) once (dose and indication: unknown; batch/lot number: 7rsl021; expiry date: not provided).On the same day, the patient presented with left knee pain and at approximately 16:00 had stabbing pain (approximately 8 hours post injection).It was reported that growth of a gram negative bacillus was detected from the synovial fluid culture collected.The next day patient presented with swollen knee and pain.The manufacturer had issued a recall.Corrective treatment: not reported for left knee pain/ stabbing pain/growth of a gram-negative bacillus was detected from the synovial fluid culture collected.Outcome: unknown for both the events seriousness criteria: medically significant for both 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 pharmacovigilance comment: sanofi company comment dated (b)(6) 2018.This case concerns a patient who presented arthritis bacterial, device malfunction after receiving treatment with synvics one.Based upon the information, the causal role of the product cannot 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
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7368790
• MDR Text Key: 103806578
• Report Number: 2246315-2018-00411
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• 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