MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS LIMB SALVAGE SYSTEM; FEMORAL HEAD, 32MM TAPER, +7MM 32MM, +7MM

Catalog Number	26010010E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2026
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 disassociation was not related to the design, manufacture, and/or sterilization of the revised implants.
Event or Problem Description
It was reported that a patient with an eleos total femur replacement underwent revision surgery on (b)(6) 2026 due to a disassociation of a microport bipolar head from an onkos femoral head.Reported that the surgeon revised putting a cup and constrained liner this report captures the eleos femoral head.This event will be reported as a serious injury due to the revision surgery.
Event or Problem Description
It was reported that a patient with an eleos total femur replacement underwent revision surgery on (b)(6)2026 due to a dislocation of an onkos femoral head from a microport bipolar shell.Reported that the surgeon revised putting a cup and constrained liner.This report captures the eleos femoral head.This event will be reported as a serious injury due to the revision surgery.
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 dslocation was not related to the design, manufacture, and/or sterilization of the revised implants.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: FEMORAL HEAD, 32MM TAPER, +7MM 32MM, +7MM
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL INC.; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 24515493
• Report Number: 3013450937-2026-00102
• Device Sequence Number: 9746198
• Product Code: KRO
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 05/05/2026

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: 26010010E
• Device Lot Number: 1901695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2021
• 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: 80 YR
• Patient Sex: Male