MAUDE Adverse Event Report: SEIKAGAKU CORPORATION SUPARTZ FX; ACID, HYALURONIC INTRAARTICULAR

Model Number	89130-4444-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a definitive report.This case is received by bioventus on (b)(6) 2024 and it was forwarded to manufacturer on (b)(6).The reporter did not provide any evaluation in term of the event.Further detailed investigation were failed with attempts on october 23, 28 and november 04, 2024 through our us partner.Based on the result of investigation for lot# 4x3x12, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring.No similar case has been reported in the use of lot 4x3x12.Any contamination within the product was therefore unlikely.It was considered that the subsequent event was not related to the product.
Event or Problem Description
On (b)(6) 2024 - a male patient received supartz fx into bilateral knees with 21g 2" needle under fluoroscopy.1.5cc omnipaque was injected for arthrogram.4cc 1% lidocaine was used for anesthesia.On (b)(6) 2024 - the patient experienced severe pain, difficulty walking/standing, increased swelling.On (b)(6) 2024 - the patient returned to the physician.X-rays were taken and cultures were drawn.The physician was concerned of septic arthritis and suggested the patient go to the emergency room.The patient was hospitalized from (b)(6) 2024.The patient was diagnosed with streptococcal septic arthritis.He was treated per infectious disease, cardiology, orthopedics.On (b)(6) 2024 - the patient was reported to be improving.The current status: following with orthopedics with possible knee replacements in the future.

• Brand Name: SUPARTZ FX
• Common Device Name: 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: 20616426
• Report Number: 9612392-2024-00016
• Device Sequence Number: 15341734
• Product Code: MOZ
• UDI-Device Identifier: 10389130444418
• UDI-Public: (01)10389130444418(17)270331(10)4X3X12
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 89130-4444-01
• Device Catalogue Number: 7156-4444
• Device Lot Number: 4X3X12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male