ELEOS¿ LIMB SALVAGE SYSTEM
Received Jun 10, 2026 · Event occurred May 20, 2026
Report 3013450937-2026-00233 · MDR key 25457806
Device
Generic name
Eleos¿ Resurfacing Femur Axial Pin Size 3
Manufacturer
Onkos Surgical Inc.Catalog number
25002113E
Lot number
1999897
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR · Female
- Medical device site infection
Narrative
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.
Description of Event or Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.