ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-040MFRecalls & reported problems
Onkos Surgical, Inc. · ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 40MM · Class 2 · Implant
All models of ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Onkos Surgical ELEOS limb salvage system is an implanted replacement for a limb or joint. The 25 reports mostly describe infections around the implant, including fungal infections, that led to revision surgery; all 25 involved injuries, with no deaths. No recalls name this device. Reports rose from 6 in the previous 12 months to 19 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI B278AMMS040MF0), received between Apr 17, 2025 and May 13, 2026 — classified as 25 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
Patient problems
- Unspecified Infection19
- Medical device site infection5
- Insufficient Information3
- Fungal Infection2
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 25161213 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDESCTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24701920 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 76-YEAR-OLD PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO A FUNGAL INFECTION AND NEEDED TO GET THEIR EXTENSOR MECHANISM REPAIRED. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Fungal Infection; Medical device site infection
MAUDE report 24598199 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 76 YEAR OLD PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO A FUNGAL INFECTION AND NEEDED TO GET THEIR EXTENSOR MECHANISM REPARIED. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDESCTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Fungal Infection; Medical device site infection
MAUDE report 24594682 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 53 YEAR OLD PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 24590468 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24148227 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT/PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24147164 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT/PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24147148 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT/PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24147097 ↗InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem
RETROSPECTIVE REPORT ENCOUNTERED THROUGH PATIENT'S PRIOR COMPLAINT HISTORY. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO UNKNOWN REASONS. COMPLAINT WILL BE REPORTED DUE TO REVISION SURGERY. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 24111250 ↗InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem
RETROSPECTIVE REPORT ENCOUNTERED THROUGH PATIENT'S PRIOR COMPLAINT HISTORY. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO UNKNOWN REASONS. COMPLAINT WILL BE REPORTED DUE TO REVISION SURGERY. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 24111247 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
RETROSPECTIVE REPORT ENCOUNTERED THROUGH A PATIENT'S COMPLAINT INVESTIGATION. A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO UNKNOWN REASONS. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 24068158 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23982749 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. IT WAS REPORTED THAT THE PATIENT IS OVER 600 LBS. THIS REPORT CAPTURES ELEOS NANOCEPT MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23811246 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23744727 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23742635 ↗InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23673900 ↗InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23673899 ↗InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 SHOWING SIGNS OF LOOSENING ON X-RAY AND ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS NANOCEPT MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23515081 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS NANOCEPT MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23418081 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 58-YEAR-OLD MALE PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. REPORTED THAT THE SURGEON SWAPPED MODULAR COMPONENTS. THIS REPORT CAPTURES THE ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23353331 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 58-YEAR-OLD MALE PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. REPORTED THAT THE SURGEON SWAPPED MODULAR COMPONENTS. THIS REPORT CAPTURES THE ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23353322 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 74-YEAR-OLD FEMALE PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT AND ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION REPLACING ALL COMPONENTS EXCEPT THE STEMS. THIS REPORT CAPTURES THE ELEOS NANOCEPT MALE-FEMAL MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23022070 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 74-YEAR-OLD FEMALE PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT AND ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION REPLACING ALL COMPONENTS EXCEPT THE STEMS. THIS REPORT CAPTURES THE ELEOS NANOCEPT MALE-FEMAL MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23022069 ↗InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 65-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.
Patient problems: Medical device site infection
MAUDE report 21860488 ↗
Other Limb And Joint Salvage Device With Coating For Bacteria Reduction devices
- ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-060MFOnkos Surgical, Inc. · Limb And Joint Salvage Device With Coating For Bacteria Reduction19 reports
- ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-050MFOnkos Surgical, Inc. · Limb And Joint Salvage Device With Coating For Bacteria Reduction14 reports
- ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-070MFOnkos Surgical, Inc. · Limb And Joint Salvage Device With Coating For Bacteria Reduction5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page