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 Code	Arthralgia (2355)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised due to femoral pain.The cr femoral component and insert were revised to a ts femoral component and insert.The sales rep confirmed there were no allegations against the revised implants, and that no further information will be released by the hospital or surgeon.

• 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: 24188053
• Report Number: 9615014-2026-00002
• Device Sequence Number: 18158807
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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
• 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: 01/06/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: TRIATHLON 3X11 CR INSERT; TRIATHLON SIZE 3 CR CEMENTED FEMORAL COMPONENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female