ELEOS¿ LIMB SALVAGE SYSTEM
Received May 13, 2026 · Event occurred Apr 20, 2026
Report 3013450937-2026-00195 · MDR key 25160806
Device
Generic name
Eleos¿ Tibial Baseplate, Size 2 65mm M/l
Manufacturer
Onkos Surgical Inc.Catalog number
TB-2202E-01M
Lot number
90732-029
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR · Female
- Joint Dislocation
- Joint Laxity
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 ADVERSE EVENT 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 AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO PATELLA BAJA. PATIENT'S PATELLA WAS REPORTED TO BE LOWER THAN IT SHOULD BE AND SLIGHTLY DISLOCATING. THIS REPORT CAPTURES ELEOS TIBIAL BASEPLATE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.