MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; TIBIAL POLY SPACER, 20MM

Catalog Number	25001220E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted with an onkos eleos distal femur replacement, experienced dislocation of the eleos poly spacer and eleos tibial hinge component.The patient underwent a revision procedure on (b)(6) 2025.This event will be reportable as a serious injury due to the revision procedure.This report captures the eleos poly spacer.
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on the review of device history records, the investigation concluded that the root cause of the reported dislocation was not likely related to the design or manufacture of the devices.The onkos surgical eleos limb salvage system ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that may contribute to adverse effects.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: TIBIAL POLY SPACER, 20MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 22391262
• Report Number: 3013450937-2025-00140
• Device Sequence Number: 9401190
• Product Code: KRO
• UDI-Device Identifier: B27825001220E0
• UDI-Public: B27825001220E0
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 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): 07/02/2025

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: 25001220E
• Device Lot Number: 1919171
• 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: 06/02/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2022
• 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 Sex: Male