MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV US

Model Number	6194-1-001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Arthralgia (2355)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient alleges allergic reaction and pending revision for both of his knee replacements.This report is for the left knee.

• Brand Name: SIMPLEX HV US
• Common Device Name: SIMPLEX HV US
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, hessen 64839 ; GM 64839
• Manufacturer (Section G): OSARTIS GMBH; auf der beune 101; muenster, hessen 64839 ; GM 64839
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, hessen 64839 ; GM 64839
• MDR Report Key: 22083246
• Report Number: 9615014-2025-00006
• Device Sequence Number: 20564427
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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 Expiration Date: 03/31/2023
• Device Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-010
• Device Lot Number: 112AB819AC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STERILE FLUTED HEADLESS 1/8PINX3.5 IN7650-2038A; TRI ASYM X3 PATELLAREF 5551-G-320-ELOT 9VJP; TRI CR FEM COMP 6 R-CEMREF 5510F601LOT NYD6P; TRI PRI TIB BPL CEM SZ 6REF 5520-B-600LOT GYT7IA; X3 TRI CS INS NO 6 9MMREF 5531-G-609-ELOT AR8XRT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male