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Hip replacement surgery [hip arthroplasty].Case (b)(6) is a serious, spontaneous case received from a non health professional via a regulatory authority in united states.This report concerns a patient (no patient identifiers reported) who had hip replacement surgery during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for unknown indication from an unknown start date and unknown if ongoing.On (b)(6) 2018, the patient was hospitalized and had hip replacement surgery.The lot number m17202a and expiration date 11-aug-2018 were reported.No additional information was provided.Action taken with euflexxa was unknown.At the time of this report, the outcome of hip replacement surgery was unknown.Concomitant medication and medical history were not 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 = mw5084490.This ae occurred in the 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 does not meet the definition of a medical device incident according to the requirements of the medical device directive/ 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.
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