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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Bacterial Infection (1735); Fever (1858); Inflammation (1932); Synovitis (2094)

Event Type  Injury  

Event Description

This case was detected in the medical literature on 18-jan-2022 from "brandariz-núñez d, gálvez-lópez j.Septic arthritis caused by bacteroides thetaiotaomicrom: a case report and review.Rev esp quimioter.2021;34(6):675-678.Doi:10.37201/req/067.2021".This spontaneous case was reported in the medical literature by a health professional from spain and concerns a (b)(6) year-old male patient who experienced anaerobic septic knee arthritis associated to bacteroides thetaiotaomicrom after arthroscopic surgery and periodic knee infiltrations of hyaluronic acid.A (b)(6) year-old male patient underwent reconstruction of the anterior cruciate ligament (acl) of his left knee in 2015 in italy.Since then, he has received hyaluronic acid injections every 6 months until the end of 2019.Since mid-february 2020, he had marked inflammation and recurrent joint effusion, requiring 2 evacuating arthrocentesis per week.On march 25, 2020, he came to the center with fever and persistent effusion in the joint.A magnetic resonance imaging (mri) was performed where abundant global synovitis and posterior extra-articular edema were observed.Synovial fluid was obtained for analysis and cultivation by arthrocentesis.The joint fluid analysis showed 41,627 leukocytes/mcl, 93.6% neutrophils and without the presence of crystals.No bacterial growth was observed after 5 days of incubation.The patient's general biochemistry revealed an erythrocyte sedimentation rate (esr) of 37 mm/h and a c-reactive protein (crp) of 3 mg/dl.The following day, arthroscopic intervention for debridement and cleaning was decided, and empiric antimicrobial therapy was started with vancomycin 1g/12h and ceftazidime 2g/8h intravenous.Four samples of synovial exudate extracted during the surgical intervention were sent to culture.Two samples were incubated in conventional plate culture, without microbial growth after five days.Two subcultures were performed for aerobic and anaerobic organisms from a liquid medium and incubated at 35° c in an environment containing 5% co2 and anaerobic chamber, respectively.The incubation system was bact/alert® (biomérieux) for five days.In one of the anaerobic samples, the system detected microbial growth after 16 hours of incubation.The anaerobic sample was seeded in medium schaedler agar (scs) observing microbial growth, under anaerobic conditions.B.Thetaiotaomicrom was identified using the matrix-assisted laser desorption ionization time of flight mass spectrometry system (maldi-tof ms, vitek ms®, biomérieux).The susceptibility test was performed with the vitek 2xl® system (biomérieux).Antibiogram for b.Thetaiotaomicrom is as follows: amoxicillin-clavulanic = susceptible (mic: 0.25 mg/l) clindamycin = resistant (mic: >256 mg/l) imipenem = susceptible (mic: 0.12 mg/l) metronidazole = susceptible (mic: 0.25 mg/l) cefoxitin = resistant chloramphenicol = resistant piperacill-tazobactam = susceptible antimicrobial treatment was modified to piperacillin-tazobactam 4.5g/8h.After 2 weeks of intravenous antimicrobial treatment, the patient was completely afebrile, with a normalized pcr (0.5 mg/dl) and esr (18 mm/h), with a flexion of the joint of 110°, without effusion, with moderate residual synovitis, mild bone edema and no intra-articular collections on mri.Hospital discharge was decided with sequential antimicrobial therapy with metronidazole 500 mg/8h, for 2 weeks.A follow-up mri was performed in july, showing complete resolution of the synovitis and edema.The patient returns to professional activity in october fully recovered.No further information is available.

• Brand Name: HYALURONIC ACID
• Type of Device: SODIUM HYALURONATE
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica 3/a; abano terme, 35031 ; SP 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
• MDR Report Key: 13550109
• MDR Text Key: 290447628
• Report Number: 9610200-2022-00001
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 33 YR
• Patient Sex: Male