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 Problems Pain (1994); Swelling (2091)

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 19-mar-2018 from the patient.This case concerns a female patient (age not provided) who initiated treatment with synvisc one and 01 day later had right knee was swollen from mid-calf to midthigh and after unknown latency had right knee effusion.Device malfunction was also identified.The patient was not on immunosuppressant therapy prior to the injection and has never had a synvisc one injection before this time.Concurrent condition of pain.No medical history, previous medications or concomitant medications were reported.On an unknown date (beginning of (b)(6)), patient received treatment with intra articular synvisc one injection at a dose of 06 ml once (batch/ lot number: 7rsl021 and expiry date: 31-mar-2020).The same day, pain began the day she received the bilateral injection.Her left knee was okay.On an unknown date (the next day), 01 day after first dose of synvisc one, when the patient woke up her right knee was swollen from mid-calf to mid-thigh.No heat or redness was there.She went to the er where she had an ultrasound done to rule out dvt.Blood work was done and was negative for infection.A dvt was not found.A few weeks after the ultrasound was when her symptoms began to improve.Her physician did not remove any fluid or give corticosteroid injections but had her take off work and recommended her ice and elevate the affected knee.Her pain was not any different than what it was before the injection.On an unknown date, after unknown latency, the patient had right knee effusion and as a result and she was admitted in er.Corrective treatment: not reported for right knee effusion; ice and knee elevated for right knee was swollen from mid-calf to mid-thigh outcome: recovering for right knee was swollen from mid-calf to mid-thigh and device malfunction; unknown for right knee effusion.Seriousness criteria: important medical event for device malfunction.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 dated 26-mar-2018.This case concerns a patient who received treatment with synvisc one from recall lot and later experienced swelling in right knee, effusion and no relief in pain.Since events occurred within one day of administration of synvisc one injection, significant temporal relationship can be established and causal role of suspect product cannot be denied in occurrence of the event.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
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7387992
• MDR Text Key: 104422308
• Report Number: 2246315-2018-00423
• 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: 03/19/2018

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?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• 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: 03/19/2018
• 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