• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FIDIA FARMACEUTICI S.P.A. HYALURONIC ACID SODIUM HYALURONATE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHYALURONIC ACID
Type of DeviceSODIUM 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 Key13550109
MDR Text Key290447628
Report Number9610200-2022-00001
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
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 Received02/17/2022
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 Received01/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/17/2022 Patient Sequence Number: 1
-
-