ELEOS™ Limb Salvage System TB-2201E-01MRecalls & reported problems
Onkos Surgical, Inc. · ELEOS™ TIBIAL BASEPLATE, SIZE 1 60MM M/L · Class 2 · Implant
All models of ELEOS Limb Salvage System (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B278TB2201E01M0), received between Oct 6, 2022 and Oct 29, 2025 — classified as 3 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 Problem3
Patient problems
- Unspecified Infection2
- Insufficient Information1
- Medical device site infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 TIBIAL BASEPLATE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 23417002 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A 71-YEAR-OLD FEMALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE JOINT INFECTION.
Patient problems: Medical device site infection
MAUDE report 21036119 ↗InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE FOLLOWING IMPLANTS WERE REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP AND ELEOS TIBIAL POLY SPACER.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 15555564 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1417United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 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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