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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This case was reported from an injecting physician.The injecting physician considered that septic arthritis was possibly related to artz dispo.We are investigating the case from an treating physician.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 septic arthritis.Manufacturer's causality assessment is determined as "not related".(b)(4).

Event Description

On (b)(6) 2020: a (b)(6) year-old male patient, who had received dozens of artz dispo injection as maintenance treatment for gonarthrosis, received an injection of artz dispo.On (b)(6) 2020: he had septic arthritis and was admitted to another hospital.It was in treatment.

Event Description

(b)(6) 2020: a (b)(6) male patient, who had received dozens of artz dispo injection as maintenance treatment for gonarthrosis, received an injection of artz dispo to right knee.(b)(6) unk: he had septic arthritis and was admitted to another hospital.It was in treatment.(b)(6) 2020: he was seen at the injection physician's clinic.His knee was improving.

Manufacturer Narrative

This is a definitive report.B5 and h10 were updated.The follow-up to the treating physician was not allowed by the injecting physician.The patient's condition was updated.The injecting physician considered that septic arthritis was possibly 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 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: 9752241
• MDR Text Key: 190516168
• Report Number: 9612392-2020-00002
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• 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: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR