Device malfunction [device malfunction], increased pain in both knees, but especially in right knee [pain in knee], swelling in both knees, but especially in right knee [swelling of knees].Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request.This unsolicited case from united states was received on 27-feb-2018 from a healthcare professional via health authority (usa-fda-food and drug administration mw5074669) this case concerns a patient (demographics unspecified) who received treatment with synvisc one and after unknown latency had increased pain in both knees, but especially in right knee and swelling in both knees, but especially in right knee.Also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication or concurrent condition was provided.On an unknown date, the patient-initiated treatment with single intra-articular synvisc one injection, once (batch/lot number: 7rsl021; dose, indication and expiry date: not reported) bilaterally.On (b)(6) 2017, after unknown latency, patient had increased pain and swelling in both knees, but especially in right knee.Corrective treatment: not reported for all events.Outcome: unknown for all 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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: medically significant for all events.Pharmacovigilance comments: sanofi company comment dated 07-mar-2018: this case concerns a patient who has received synvisc one injection in both knees from the recalled lot and later experienced pain and swelling in both knees, especially in right knee.Since the events occured after synvic administration, a causal role cannot be denied.Further, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.
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