MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYALURONIC ACID

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Septic Shock (2068)

Event Type  Death  

Manufacturer Narrative

(b)(4).The literature case comes from an (b)(6) article.The patient after the injection of a product containing hyaluronic acid as active substance experienced septic arthritis, systemic infection.The outcome of the adverse reactions was fatal.The case has been deemed by the company as serious due to fatal event and unexpected due to the adr systemic infection.The causality relationship has been deemed as possible by the company because the adrs could have been caused by poor asepsis injection procedure or other exsisting concomitant conditions.The company contacted the reporter to have further information on the product and the reporter stated that it was not possible to know the trade name of the product used and also the exact molecular weight of the hyaluronic acid.The case is reported as an active ingredient case.No new signal alert has been detected.The paper reference is: case rep orthop.2017;2017:1518401.Doi: 10.1155/2017/1518401.Epub 2017 feb 23.A fatal sepsis caused by hyaluronate knee injection: how much the medical history and the informed consent might be important? manfreda f, rinonapoli g, nardi a, antinolfi p, caraffa a.The device is not available.

Event Description

The patient is a (b)(6) male affected by bilateral knee oa.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.So he was submitted to an intra-articular hyaluronate injection, without immediate complications.A high molec-ular 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 has been conducted.About 48 hours after that, 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 hospitalized.The input 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 positive results for two different atypical microorganisms: multi resistant escherichia coli and multi resistant klebsiella.Specific antibiogram had shown sensitivity to very few antibiotics for this kind of bacteria.A combination of vancomycin (500 mg i.V., 4 times a day) and cephalosporin (ceftriaxone 2 gr i.V., twice daily) was used for the full treatment.Anyway, twelve days after admission, the patient pre-sented 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.In fact, he did not report any positive response to stimulation and paralysis was complete and permanent.He has been 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: a severe septic arthritis of the knee and osteomyelitis of tibia and femur were confirmed.Surgical debridement of the knee and the leg was per-formed 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 features have 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 has made self-contained 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.

• Brand Name: HYALURONIC ACID
• Type of Device: HYALURONIC ACID
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer (Section G): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer Contact: giuseppe di sante ; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031 ; 0498232827
• MDR Report Key: 6492747
• MDR Text Key: 72786106
• Report Number: 9610200-2017-00001
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2017
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BETA BLOCKERS; CORTICOSTEROIDS
• Patient Outcome(s): Death
• Patient Age: 59 YR