MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS¿ LIMB SALVAGE SYSTEM; ELEOS¿ TIBIAL POLY SPACER

Catalog Number	25001210E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
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 dislocated knee 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 proximal femur replacement underwent revision surgery on (b)(6) 2025.Patient dislocated their knee.Only the poly spacer was swapped and revised.This report captures eleos poly spacer.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 due to the insufficient information provided to do a full investigation on the devices history.An mdr has been submitted due to the adverse event.If more information is attained, then this mdr report will be updated.
Event or Problem Description
It was reported by an onkos sales representative, that a patient with eleos proximal femur replacement underwent revision surgery on (b)(6) 2025.Patient dislocated their knee.Only the poly spacer was swapped and revised.This report captures eleos poly spacer.This event will be reported as a serious injury due to the revision procedure.

• Brand Name: ELEOS¿ LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS¿ TIBIAL POLY SPACER
• 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: 23616998
• Report Number: 3013450937-2025-00362
• Device Sequence Number: 18664687
• Product Code: KRO
• UDI-Device Identifier: B27825001210E0
• UDI-Public: B27825001210E0
• 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 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): 11/21/2025

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
• Device Catalogue Number: 25001210E
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/20/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female