MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV

Model Number	6194-1-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Implant Pain (4561)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a total knee revision procedure, the patient developed a post-operative knee infection.Consequently, the existing 3 x 11 revision poly insert was removed and replaced with a new 3 x 11 revision poly insert.

• Brand Name: SIMPLEX HV
• Common Device Name: SIMPLEX HV
• 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: 25589851
• Report Number: 9615014-2026-00003
• Device Sequence Number: 10280547
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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 Model Number: 6194-1-001
• Device Catalogue Number: 6194-1-010
• Device Lot Number: 527AB826EG
• 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: 05/29/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2025
• 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 CEMENTED STEM 12MMX50MMLOT 1203242K.; TRI CEMENTED STEM 12MMX50MMLOT 1832926J,; TRI TS FEMUR SZ2 LEFTLOT TE44E,; TRIATH FEM DISTAL AUG 5MM - SIZE 2 LEFTLOT SGA9T,; TRIATHLON FEM DIST AUG 10MM SIZE 2 LEFTLOT S4Z4D,; TRIATHLON HINGE B/PLATE SIZE 3LOT 49L2P,; TRIATHLON REVISION INSERT X3 SZ3 11MMLOT J51900,; TRIATHLON STEM EXTENDER 25MMLOT R0061H,
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female