MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS¿ LIMB SALVAGE SYSTEM; ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 28MM COLLAR

Catalog Number	FS-11120-03M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised on (b)(6) 2025 and presented evidence of loosening around the femoral stem.
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 loosening was not related to the design, manufacture, and/or sterilization of the revised implant.

• Brand Name: ELEOS¿ LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 28MM COLLAR
• 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: 25325136
• Report Number: 3013450937-2026-00223
• Device Sequence Number: 9986094
• Product Code: KRO
• UDI-Device Identifier: B278FS1112003M0
• UDI-Public: B278FS1112003M0
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: FS-11120-03M
• Device Lot Number: 81691R-003
• 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: 01/28/2026
• Initial Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 01/18/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male