ELEOS LIMB SALVAGE SYSTEM
Received Jun 25, 2026
Report 3013450937-2026-00226 · MDR key 25622408
Device
Generic name
Eleos Tibial Poly Spacer
Manufacturer
Onkos SurgicalProduct problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THROUGH ANOTHER PRODUCT COMPLAINT REPORT, IT WAS IDENTIFIED THAT THE PATIENT'S PROCEDURE ON (B)(6) 2021 WAS A REVISION SURGERY WHICH WAS NOT PREVIOUSLY REPORTED AS A COMPLAINT. THE PATIENT'S INDEX SURGERY COULD NOT BE IDENTIFIED; THEREFORE, THE DEVICES WHICH WERE IMPLANTED IN THE PATIENT ARE UNKNOWN. ADDITIONALLY, THE REASON FOR THE REVISION ON (B)(6) 2021 IS NOT KNOWN. AS THE FAILURE MODE AND DEVICE INFORMATION IS NOT KNOWN, FURTHER INVESTIGATION COULD NOT TAKE PLACE. THEREFORE, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION.
Description of Event or Problem
A PATIENT WITH ELEOS LIMB SALVAGE SYSTEM WAS REVISED ON (B)(6) 2021. THE REASON FOR REVISION IS NOT KNOWN. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.