MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV; SIMPLEX HV WITH GENTA

Model Number	6195-1-001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Arthralgia (2355)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right total knee replacement on (b)(6) 2024.In late (b)(6), the patient allegedly developed increasing pain and functional impairment.The patient was revised on (b)(6) 2025 due to the alleged "failure of the polyethylene liner, which permitted abnormal movement and misalignment of the femoral and tibial components".

• Brand Name: SIMPLEX HV
• Common Device Name: SIMPLEX HV WITH GENTA
• 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, hesse 64839 ; GM 64839
• MDR Report Key: 25634353
• Report Number: 9615014-2026-00004
• Device Sequence Number: 9398959
• Product Code: MBB
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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: 04/30/2025
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-010
• Device Lot Number: 317BB844EE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRI TS BASEPLATE SIZE 3: LOT RHL9XB.; TRIATHLON ASYMMETRIC X3 PATELLA: LOT NJ36.; TRIATHLON CR FEM COMP #4 R-CEM: LOT U72UE.; X3 TRIATHLON CS INSERT NO 3 11MM: LOT M93AV3.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female