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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

According to the injecting physician, there were no issues on aseptic manipulation of the injection.It was considered that the septic arthritis was possibly related to artz dispo.Company comment: we are requesting further information on the case.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 septic arthritis.Manufacturer's causality assessment is determined as "not related".(b)(4).

Event Description

On (b)(6) 2019: a (b)(6) year-old female patient received an injection of artz dispo for left gonarthrosis.On (b)(6) 2019: she had septic arthritis.2019-unk - she was admitted and had an operation at another hospital.

Event Description

(b)(6) 2019 - a 58 year-old female patient received an injection of artz dispo for left gonarthrosis.(b)(6) 2019 - she had septic arthritis.2019-unk - she was admitted and had an operation at another hospital.Unk - she recovered.

Manufacturer Narrative

According to the injecting physician, there were no issues on aseptic manipulation of the injection.It was considered that the septic arthritis was possibly related to artz dispo.Company comment: this is a definitive report.The physician denies to provide further information.The outcome was changed "recovered " from "recovering".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 septic arthritis.Manufacturer's causality assessment is determined as "not related".We selected the code of 4316(appropriate term/code not available) for h.6 manufacturer evaluation conclusion code because the reported adverse event was not listed in the package insert and concerned lot number was not available.

• 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
• MDR Report Key: 9828943
• MDR Text Key: 190516646
• Report Number: 9612392-2020-00003
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR