This case was cross-referred with (b)(4) (cluster cases) this spontaneous case from united states was received on 29-jan-2018 from health care professional this case concerns a (b)(6) female patient who initiated treatment with synvisc one and experienced large effusions in both knees after injections, significant pain/continued pain right worse than left and swelling right worse than left.Also, device malfunction was identified for the reported lot number no previous medications and concurrent conditions were reported.Patient had medical history of knee disorders(bilateral), arthroscopy and bilateral osteoarthritis.Concomitant medications included naproxen sodium (aleve).On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (batch/ lot number, dose, expiry date: unknown) for osteoarthritis bilateral knees.The same day, patient developed large effusions in both knees after injections, significant pain/continued pain right worse than left and swelling right worse than left.On an unknown date, patient recovered from large effusions in both knees after injections, significant pain/continued pain right worse than left and swelling right worse than left outcome: recovered for all 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Pharmacovigilance comment: sanofi company comment dated 06-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and experienced large effusions in both knees after injections, developed significant pain/continued pain right worse than left and swelling right worse than left.The events are temporally related to device.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.
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