ELEOS¿ LIMB SALVAGE SYSTEM
Received Jul 8, 2026 · Event occurred Jun 4, 2026
Report 3013450937-2026-00250 · MDR key 25753088
Device
Generic name
Eleos¿ Distal Femur Axial Pin One Size
Manufacturer
Onkos Surgical Inc.Catalog number
25002111E
Lot number
2056529
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
80 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 PERIPROSTHETIC JOINT INFECTION. PATIENT PROCEEDED WITH FOLLOW-UP TREATMENT, MULTI-STAGE INFECTION TREATMENT WAS PERFORMED ON (B)(6) 2026. THIS REPORT CAPTURES ELEOS AXIAL PIN. 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.