MAUDE Adverse Event Report: SEIKAGAKU CORPORATION ARTZ DISPO; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 5L3C08

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

Patient Problem Bacterial Infection (1735)

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

We are investigating the production records.This case was reported from a physician.The lot number of artz dispo was 5l3c08.The patient was transported urgently and we couldn't investigate because information on transported hospital was not obtained.According to the reporting physician, the injection technique was no problem, because there were no problems for the first and second injections.The physician disinfected the knee with isodine and wore gloves.The physician instructed him to rest and take no bathing.It was considered that infection accidentally happened, and septic arthritis was highly probably related to artz dispo.Company comment: all of product batches passed with the release test including the sterility test before the product release.It is therefore highly unlikely that the product quality was related to the infection.The manufacturer's causality assessment is determined as "not related".

Event Description

(b)(6) 2023 - a 91-year-old male patient received an injection of artz dispo for right gonarthrosis.(b)(6) 2023 - he received an injection of artz dispo.(b)(6) 2023 - he received an injection of artz dispo.(b)(6) 2023 - he had pain and swelling on the right knee from the night.(b)(6) 2023 - he visited the clinic.He had septic arthritis.A physician confirmed knee effusion and prescribed levofloxacin half tablet/day and acetaminophen 300 mg two tablets/day.He had a blood test.(b)(6) 2023 - he finished taking levofloxacin half tablet/day and acetaminophen 300 mg two tablets/day.(b)(6) 2023 - he was transported urgently.(b)(6) 2023 - the outcome was not resolved.

Manufacturer Narrative

This is a definitive report.We corrected h.6 adverse event problem of fda investigation findings from 3221 to 213, and fda investigation conclusions from 11 to 67.We had the result of investigations for no.5l3c08 and changed company comment below.According to the reporting physician, the injection technique was no problem, because there were no problems for the first and second injections.The physician disinfected the knee with isodine and wore gloves.The physician instructed him to rest and take no bathing.It was considered that infection accidentally happened, and septic arthritis was highly probably related to artz dispo.Company comment: according to the result of investigations, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot no.5l3c08.Manufacturer's causality assessment is determined as "not related".

• Brand Name: ARTZ DISPO
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• Manufacturer (Section G): SEIKAGAKU CORPORATION - TAKAHAGI PLANT; 258-5, aza-matsukubo; oaza-akahama; takahagi-shi, ibaraki 318-0 001; JA 318-0001
• Manufacturer Contact: pharmacovigilance dept. ; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005 ; JA 100-0005
• MDR Report Key: 17623117
• MDR Text Key: 321939659
• Report Number: 9612392-2023-00004
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 5L3C08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 91 YR
• Patient Sex: Male