Suspicion of septic arthritis [arthritis bacterial].Case (b)(6) is a serious spontaneous case received from a physician in (b)(6).This report concerns a (b)(6)-year-old female, who experienced suspicion of septic arthritis during treatment with intra-articular arthrease (sodium hyaluronate) solution for injection, unknown concentration, at a dose of 1 injection in both knees, for osteoarthritis on (b)(6) 2019.Batch number not available.The patient`s medical history included diabetes, eczema on legs, osteoarthritis in both knees, metabolic syndrome and bmi >35.Due to the patient's complex medical condition, surgical management was not an option and although her knees where ruined, arthrease was suggested to provide some relief.On (b)(6) 2019, the physician injected artherase to both knees: on one knee, there were no issues, but on the other knee, after the injection the patient experienced extreme pain, that did not resolve.The physician performed an articular puncture and the extracted synovial fluid was bloody.An analysis of the synovial fluid revealed increased leukocytes (over 80,000); no bacterial presence was noted.The patient also had an increased crp.Following the articular leukocytosis, septic arthrosis was suspected and the patient was hospitalized.Action taken to arthrease was unknown.At the time of the report, the patient was still in a hospital and the outcome was not recovered.No concomitant medication was reported.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: internal # - (b)(4).This ae occurred in (b)(6) and concerns the medical device arthrease.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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