ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-050MFRecalls & reported problems
Onkos Surgical, Inc. · ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 50MM · 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
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI B278AMMS050MF0), received between Sep 10, 2025 and Jun 10, 2026 — classified as 14 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 Problem14
Patient problems
- Unspecified Infection8
- Medical device site infection3
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. SURGEON PERFORMED WASHOUT AND SWAPPED MODULAR COMPONENTS. 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 25456819 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 79-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO DISLOCATION OF MIDSECTION FROM DISTAL FEMUR BODY. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24800193 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. SURGEON PERFORMED I&D WITH MODULAR COMPONENT SWAP. 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 24626285 ↗InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 74-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 24512864 ↗InjuryFeb 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 UNDISCLOSED 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 24465705 ↗InjuryJan 21, 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 24138403 ↗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 24068161 ↗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 23418083 ↗InjuryOct 23, 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 68-YEAR-OLD FEMALE 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 23375854 ↗InjuryOct 23, 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 68-YEAR-OLD FEMALE 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 23375853 ↗InjurySep 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 74-YEAR-OLD MALE PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES THE 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 23051173 ↗InjurySep 12, 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 67-YEAR-OLD FEMALE PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES THE 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 23037103 ↗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 23022091 ↗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 23022068 ↗
Other Limb And Joint Salvage Device With Coating For Bacteria Reduction devices
- ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY AM-MS-040MFOnkos Surgical, Inc. · Limb And Joint Salvage Device With Coating For Bacteria Reduction25 reports
- 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-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.
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