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

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 03/11/2018

Event Type  Injury  

Manufacturer Narrative

This case was found in scientific literature search.The biographical information of the scientific literature is as follows.Zhao y, et al.Suppurative knee arthritis caused by pasteurella multocida: a case report and literature review.China tropical medicine 2023; 23 (9): 1007-1010.Http://www.Cntropmed.Com/en/10.13604/j.Cnki.46-1064/r.2023.09.21 the product name of sodium hyaluronate was not identified; however we cannot rule out a possibility that our product was used completely because artz dispo is marketed in china.Even if the product was artz dispo, all of our product batches passed with the release.It is therefore highly unlikely that our product causes suppurative knee arthritis.It was considered that the event was not related to the product.

Event Description

The infected person was a 76-year-old female patient with a 5-year history of intermittent pain in her right knee and suffered from joint swelling, aggravation pain, and limited flexion and extension activities after intraarticular injection of sodium hyaluronate.After admission and completing all necessary tests, the patient was later confirmed to have been infected with pasteurella multocida.The patient's right knee was promptly examined and cleared under arthroscopic surgery, synovium and meniscus were excised, a drainage tube was inserted, and continuous joint cavity irrigation was performed after the surgery, and then ceftriaxone was injected and amoxicillin/clavulanate potassium was taken orally for anti-infection and the patient's condition improved significantly after 26 days.~ extracted from abstract ~.

• 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: marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005
• MDR Report Key: 18397874
• MDR Text Key: 331382177
• Report Number: 9612392-2023-00006
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other
• Patient Age: 76 YR
• Patient Sex: Female