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 No Code Available (3191)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 20-apr-2018 from patient this case concerns (b)(6) female patient who initiated treatment with synvisc one and after an unknown latency she was limiting around; had swollen knee and her whole leg was swollen, swollen knee and my whole leg was swollen; knee blew up; after 9 days had aspirated her knee.It was reported that patient received the contaminated shot (synvisc-one) no previous medications and concurrent conditions were reported.Patient had arthritis and had her right knee replaced and took paracetamol (tylenol) and naproxen sodium (aleve) whenever required (concomitant medication).On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml (frequency and indication: unknown) (batch/ lot number: 7rsl021 and expiry date: 31-may-2020).On (b)(6) 2017 after a latency of 9 days, patient had her knee aspirated which was horrible.Patient was limiting around and using a cane.On an unknown date after an unknown latency patient had swollen knee and her whole leg was swollen.Patient took tramadol and tylenol as corrective treatment: not reported for swollen knee and my whole leg was swollen; cane user for i was limiting around; cleaned out, tramadol and tylenol for aspirated my knee outcome: unknown for all events.Seriousness criteria: disability for received the contaminated shot (synvisc-one) and i was limiting around 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Pharmacovigilance comment: sanofi company comment 25-apr-2018: this case concerns a patient who has received synvisc one injection on left knee from the recalled lot and had swelling of knee(unspecified) leading to cleaning of the affected knee.It is unknown whether the event occurred in the injected knee.Moreover, 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
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7483496
• MDR Text Key: 107995408
• Report Number: 2246315-2018-00469
• 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: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• 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): Disability
• Patient Age: 71 YR
• Patient Weight: 81