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
Additional Manufacturer Narrative
All inspection and manufacturing data of the device was reviewed; the lot was found to be conforming to specifications, and no manufacturing abnormalities were observed.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, manufacture, and/or sterilization of the devices.The onkos distal femoral replacement 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.
Event or Problem Description
It was reported that a patient implanted with an eleos distal femoral replacement underwent a revision procedure due to dislocation of their eleos poly spacer.The patient was revised on (b)(6) 2025.This event will be reported to the fda as a serious injury due to the revision procedure.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: TIBIAL POLY SPACER, 20MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 22390360
• Report Number: 3013450937-2025-00139
• Device Sequence Number: 15701922
• Product Code: LPH
• UDI-Device Identifier: B27825001220E0
• UDI-Public: B27825001220E0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• 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 Expiration Date: 06/05/2026
• Device Catalogue Number: 25001220E
• Device Lot Number: 1751066
• 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: 06/05/2018
• 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