Knee locked up in the shower and would not bend [joint lock], intractable vomiting [vomiting], stomach sensitive [abdominal discomfort], headache [headache], nausea [nausea].Case (b)(4) is a serious, spontaneous case received from a consumer via a regulatory authority in united states.This report concerns a patient (no patient identifiers provided) whose knee locked up in the shower and would not bend, experienced intractable vomiting, stomach sensitive, headache and nausea during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for osteoarthritis from (b)(6) 2019.The patient reported that after the first injection of euflexxa on (b)(6) 2019, the patient experienced a headache the first day, intractable vomiting began approximately 22 hours later and the patient was unable to keep food or fluids down for 60 hours.Nausea lasted six days total and stomach was still sensitive.The patient's knee locked up in the shower and would not bend.The patient declined any further injections.The patient reported that they have me/cfs (myalgic encephalomyelitis/chronic fatigue syndrome) and have an overactive immune response and thought it possible that their body saw the euflexxa as in invader of some type.No additional information was provided.Action taken with euflexxa was dose withdrawn.At the time of this report, the outcome of knee locked up in the shower and would not bend was unknown, the outcome of stomach sensitive was not recovered.The outcome of intractable vomiting, nausea and headache were recovered.The patient`s medical history was significant for me/cfs (myalgic encephalomyelitis/chronic fatigue syndrome).The following concomitant medications were reported: synthroid, cytomel, prevacid, vitamin d3, vitamin b12, vitamin b1 and calcium.The event knee locked up in the shower and would not bend was reported as serious.The events intractable vomiting, stomach sensitive, headache, nausea were reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related, company causality: related: knee locked up; not related intractable vomiting, stomach sensitive, headache, nausea.Other case numbers: internal # - others = mw5084268.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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