MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; POLY SPACER, 16MM

Catalog Number	25001216E
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted with an onkos eleos proximal tibial replacement, experienced dislocation of the eleos poly spacer and eleos tibial hinge component.The patient will undergo a revision procedure at an unknown date to address the dislocation.This event will be reportable as a serious injury due to the scheduled revision procedure.
Additional Manufacturer Narrative
The root cause of this complaint was not determined based on the available information.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 and/or manufacture of the devices.Devices were not returned for evaluation.
Additional Manufacturer Narrative
Additional information regarding device explantation date was received.Section da, db, g3, and g6 were updated.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: POLY SPACER, 16MM
• 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: 21327374
• Report Number: 3013450937-2025-00006
• Device Sequence Number: 7865726
• Product Code: KRO
• UDI-Device Identifier: B27825001216E0
• UDI-Public: B27825001216E0
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 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: 25001216E
• Device Lot Number: 1901377
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 06/02/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/02/2025; 07/02/2025
• 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 Sex: Male