This case was cross referred with case: (b)(4) (cluster) this spontaneous case from united states was received on 30-jan-2018 from healthcare professional this case concerns (b)(6) female patient who initiated treatment with synvisc one and after an unknown latency had lot of pain in right knee.Also a device malfunction was note for the reported lot number.No previous medications and concomitant medications were reported.Patient had compartmental chondral disease, large ganglion adjacent to medial tibial plateau, tricompartmental osteoarthritis and was acl deficient.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml (frequency: not provided) (batch/ lot number: 7rsl021 and expiry date: may-2020) for osteoarthritis.On an unknown date after an unknown latency, patient had lot of pain in right knee.She was advised to ice and use 800 mg ibuprofen every 6 hrs.Corrective treatment: ice and ibuprofen for lot of pain in right knee outcome: unknown for both events 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: 30-jan-2018: this case concerns a female patient who received synvisc one.Later patient had and later had right knee pain.A temporal relationship can be established with the product administration.Also, the concerned lot number has been identified to have malfunction by the company.Thus, the causal relationship of the events to the products cannot be excluded.
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