MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS¿ LIMB SALVAGE SYSTEM; ELEOS¿ RESURFACING FEMUR AXIAL PIN SIZE 2

Catalog Number	25002112E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an onkos sales representative, that a patient with eleos distal femur replacement underwent revision surgery on (b)(6) 2025 due to an alleged infection.This report captures eleos axial pin.This event will be reported as a serious injury due to the revision procedure.
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on the review of known device history records, the investigation concluded that the root cause of the alleged infection was not related to the design, manufacture, and/or sterilization of the revised implants.
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on the review of known device history records, the investigation concluded that the root cause of the alleged infection was not related to the design, manufacture, and/or sterilization of the revised implants.
Event or Problem Description
It was reported by an onkos sales representative, that a patient with eleos hinge knee replacement was reportedly due to revision due to an alleged infection; however, there is no indication that the revision surgery took place and no evidence that onkos devices were revised.It was later reported that the patient had an abnormal growth unrelated to an onkos eleos implant that required removal.A supplemental mdr will be submitted to clarify that there was no reported failure of onkos devices.This mdr captures the review of eleos axial pin.

• Brand Name: ELEOS¿ LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS¿ RESURFACING FEMUR AXIAL PIN SIZE 2
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 e halsey road; parsippany 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 23583518
• Report Number: 3013450937-2025-00342
• Device Sequence Number: 13144919
• Product Code: KRO
• UDI-Device Identifier: B27825002112E0
• UDI-Public: B27825002112E0
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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
• Device Catalogue Number: 25002112E
• Device Lot Number: 1888414
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female