Septic unspecified knee [arthritis bacterial].Case (b)(4) is a serious spontaneous case received from a physician via sales representative in united states.This report concerns a patient (no identifiers reported) who experienced septic unspecified knee during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and frequency for an unknown indication from (b)(6) 2020 to an unknown stop date.The physician reported the patient developed septic unspecified knee after undergoing series of euflexxa injections two weeks ago ((b)(6) 2020).No additional information the septic unspecified knee was medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of septic unspecified knee was unknown.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = (b)(4).This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.Ferring's sender comment: despite the limited information about the patient's medical and concomitant medications history, therapy details for euflexxa (indication of use, stop date, and route of adminstration) and event details (clinical course, event onset date, and outcome), association of euflexxa to septic joint event is unrelated due to lack of biological plausibility.The event is more likely due to incorrect guidelines for clean aseptic procedure of injection or underlying bacterial infection which were not reported.
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