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Fatal sepsis [sepsis].This serious literature-spontaneous report from (b)(6) was published in a medical journal.This report concerns a (b)(6) male patient affected by bilateral knee osteoarthritis (oa) during treatment with intra-articular, sodium hyaluronate infusion for injection of unknown daily dose for osteoarthritis of the knee from an unknown start date to an unknown stop date.He had already been subjected to surgical intervention of total hip arthroplasty for hip oa.Past medical features included a severe obesity, with a body mass index higher than 32, chronic bronchial asthma treated with steroid drugs, and systemic arterial hypertension treated with beta-blockers.Vas score corresponded to 8-9.Knee x-rays had shown specific characters of articular oa that could be categorized as grade 3 of disease according to kellgren-lawrence scale.His right knee pain was difficult to control with conservative measures, including nsaids and narcotics.Oral steroid drugs were improved by his family physician in order to get pain relief but with no benefits.He was then submitted to an intra-articular hyaluronate injection, without immediate complications.A high molecular weight hyaluronic acid has been used (about 1200 kda).Cleaning technique was employed prior to the treatment, including the use of antiseptic solution and sterile gloves; sterile infiltrative practice in clean condition had been conducted.About 48 hours after intra-articular hyaluronate injection, he reported a severe fever, at about 102.2 fahrenheit/39 celsius.Antipyretic drugs did not decrease body temperature and in a few hours his general clinical conditions got worse.Approx 72 hours after the injection, he was hospitalised.The diagnosis was septic shock, which was quickly treated with adequate antibiotic and support therapy.Crp and esr values reported a gradual reduction and the shock had a quick remission.Blood and knee synovial fluid cultures had clear and dramatic positive results for two different atypical microorganisms: multiresistant escherichia coli and multiresistant klebsiella.Specific antibiogram had shown sensitivity to very few antibiotics for this kind of bacteria.A combination of vancomycin (500mg i.V., 4 times a day) and cephalosporin (ceftriaxone 2 gr i.V., twice daily) was used for the full treatment.Approx 12 days after admission, the patient presented a complete flaccid paralysis.An encephalic and spinal mri was performed, showing a septic involvement of more than two vertebrae, in particular from c5 to c7, and the corresponding cervical spinal cord.The patient was mainly assisted by the spinal unit of our hospital which cooperated with the orthopedic team.Neurologists performed a proper evaluation of spinal function by the asia standard neurological classification of spinal cord injury, results were inauspicious.The patient had not any positive response to stimulation and paralysis was complete and permanent.The patient was treated with an intensive rehabilitation program for several weeks.Meanwhile, he presented a fistula in the proximal region of the leg.So, a new knee x-ray and an mri were conducted which showed a severe septic arthritis of the knee and osteomyelitis of tibia and femur were confirmed.Surgical debridement of the knee and the leg was performed in order to reduce their septic involvement.Despite his rehab program, the patient did not report any neurological improvements; at a 5-week follow-up, a new cephalic and cervical mri showed worse conditions: septic involvement of cervical spine and spinal cord.X-ray and mri showed both knee septic arthritis and tibial and femur osteomyelitis.Features had been found in cerebral ventricles, and spinal disease became larger than before: almost the full cervical spine (c2-c7) was involved by the infection.The higher spinal cord involvement had made selfcontained breathing impossible.Thus, the patient started artificial breathing.At about four months from the entrance to the hospital, breath complications arose, which led to a poor prognosis.The patient died because of severe acquired pneumonia, caused by pseudomonas aeruginosa.In the discussion section of the published article, it was mentioned that sodium hyaluronate injection is contraindicated if skin disease or current infection is present at the injection site, but there is no mention of contraindication for viscosupplementation in immunosuppressed patients or patients with underlying malignancy.The patient was used to take steroid drugs for his chronic asthma, and there is strong evidence about a connection between chronic steroid therapy with both immunosuppression and increase of atypical infection.He was affected by two uncommon bacteria for joints that presented resistance to several antibiotics, with poor sensibility to vancomycin and cephalosporin.Antibiotic resistance has caused a poor response to therapy.It was possible that chronic steroids, which had been increased to relieve pain, could have caused an atypical infection.This could also have been the cause of rapid spreading of infection from joint to bloodstream.Then, there is strong evidence about increased risk of infection in case of obesity; the patient was not used to practicing any sport activity and he had a very high bmi.It is unknown exactly how bacteria had been inoculated in his joint.It might have been the source of inoculation in this immunodepressive condition.Clinical history of patients should be accurately examined in order to decide proper treatment options related to comorbidities and to evaluate risks of complications related to invasive action.A proper and accurate evaluation of the clinical history of patients and the acquirement of clear consensus are essential for every kind of medical action towards patients.Joint injection, too, should be considered as an invasive treatment.Clean careful practice is recommended by using sterile gloves, sterile materials, and clean procedure.It should be noted that there are no international common agreements about guidelines for implementation of clean and aseptic technique].Apart from complications, the debate about long-term effectiveness of intra-articular hyaluronate for oa is always open.At the time of reporting the case outcome was fatal.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.This ae occurred in (b)(6) and concerns the medical device sodium hyaluronate (trade name unknown).Please report to your local health authority if required by local law.This ae is reportable in eu because it does 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.No corrective action was done by the manufacturer or requested by regulators.(b)(4).
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