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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.
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Manufacturer (Section D)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
bridgewater, NJ 08807
MDR Report Key7387992
MDR Text Key104422308
Report Number2246315-2018-00423
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
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 Received04/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/02/2018 Patient Sequence Number: 1