ELEOS¿ LIMB SALVAGE SYSTEM
Received Jun 10, 2026 · Event occurred May 15, 2026
Report 3013450937-2026-00231 · MDR key 25457130
Device
Generic name
Eleos¿ Tibial Poly Spacer 12mm
Manufacturer
Onkos Surgical Inc.Catalog number
25001212E
Lot number
2000767
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Female
- Medical device site infection
Narrative
Description of Event or Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
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 INFECTION WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED IMPLANTS.