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

Model Number 89130-4444-01

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

Patient Problem Arthritis (1723)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.This case is received by bioventus on november 23, 2022 and it was forwarded to manufacturer on november 27.Additional information was provided on december 15 and 17 by bioventus.The injection site joint inflammatory reaction was probably related to the supartz fx because it developed within 24 hours after the injection.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 the lot 4x2e17.No similar case has been reported in the use of lot 4x2e17.Any contamination within the product was therefore unlikely.It was considered that the subsequent event was not related to the product.(b)(4).

Event Description

(b)(6) 2022 - a female patient received her 2nd supartz fx injection into the knee for oa.(b)(6) 2022 - the patient had a large effusion and pain.The patient was brought to the injecting physician.The physician removed clear fluid from the effusion and sent it to the lab for cultures.The patient was diagnosed with pseudoseptic reaction.The patient was started on an antibiotic cephalexin prophylactically.The aspirated fluid was high cell count over 50k.The cultures showed no bacteria growth after 3 days and no signs of crystals.(b)(6) 2022 - the patient continued experiencing pain and went to the emergency room where she was admitted.The patient underwent arthroscopy and drainage of a large knee effusion.Cultures taken from the surgery showed the patient had a strep infection.The patient responded to the treatment well.

• Brand Name: SUPARTZ FX
• 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: 16014120
• MDR Text Key: 305799443
• Report Number: 9612392-2022-00008
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2022

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
• Device Operator: Health Professional
• Device Model Number: 89130-4444-01
• Device Catalogue Number: 7156-4444
• Device Lot Number: 4X2E17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2022
• Initial Date FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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): Required Intervention; Hospitalization
• Patient Sex: Female