MAUDE Adverse Event Report: ONKOS SURGICAL INC ELEOS LIMB SALVAGE SYSTEM; ELEOS¿ RESURFACING FEMUR, SIZE 2, RIGHT

Catalog Number	RF-R002E-01M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/29/2025
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 alleged loosening was not related to the design, manufacture, and/or sterilization of the revised implants.
Event or Problem Description
It was reported by (b)(6), and onkos sales representative, that a 22-year-old female patient with an eleos proximal tibia replacement underwent a revision surgery on (b)(6) 2025 due to loosening on the femoral side.This report captures the eleos resurfacing femur.This event will be reported as a serious injury due to the revision procedure.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS¿ RESURFACING FEMUR, SIZE 2, RIGHT
• Manufacturer (Section D): ONKOS SURGICAL INC; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauer ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 22797832
• Report Number: 3013450937-2025-00165
• Device Sequence Number: 12889616
• Product Code: KRO
• UDI-Device Identifier: B278RFR002E01M0
• UDI-Public: B278RFR002E01M0
• 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: 2022
• 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
• Report Date (Section B): 08/13/2025

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: RF-R002E-01M
• Device Lot Number: P210493-004
• 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: 07/01/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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: 22 YR
• Patient Sex: Female