ELEOS™ THSMWRS01MRecalls & reported problems
Onkos Surgical, Inc. · ELEOS™ TIBIAL HINGE W/ ROTATIONAL STOP ONE SIZE · Class 2 · Implant
All models of ELEOS (127)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Onkos Eleos tibial hinge is a cemented knee implant used in knee replacement surgery. Many of its 190 reports describe patients needing revision surgery, most often for an alleged infection, and some describe joint dislocation. There are 188 injury reports and no deaths. No recalls name this device.
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
- 190
- Deaths reported
- 0
- Injuries reported
- 188
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 190 adverse event reports that list this exact device (DI B278THSMWRS01M0), received between May 17, 2021 and Jun 25, 2026 — classified as 188 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).
11 other recalls cover devices cleared under the same FDA submission (K161520); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem182
- Insufficient Device Problem Information5
- Device Dislodged or Dislocated3
- Fracture2
- Detachment of Device or Device Component1
- Mechanical Problem1
- Unintended Movement1
Patient problems
- Unspecified Infection94
- Medical device site infection67
- Insufficient Information23
- Joint Dislocation12
- Joint Laxity4
- Fall3
- Loss of Range of Motion2
- Pain2
Recent adverse event reports
The 25 most recent of 190 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 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) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 25621638 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 25457807 ↗InjuryMay 27, 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. PATIENT UNDERWENT A BILATERAL REVISION SURGERY. THIS REPORT CAPTURES ELEOS TIBIAL HINGE (LEFT). THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 25302905 ↗InjuryMay 20, 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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 25229968 ↗InjuryMay 20, 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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 25229615 ↗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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 25161212 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use 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 HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 25160815 ↗InjuryMay 4, 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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY.
Patient problems: Medical device site infection
MAUDE report 25068221 ↗InjuryMay 1, 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) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 25060095 ↗InjuryApr 23, 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) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24971931 ↗InjuryApr 16, 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) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24895702 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS HIMGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 24701178 ↗InjuryMar 25, 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. PATIENT HAD PERIPROSTHETIC FRACTURE AND REQUIRES REVISION WITH NEW FIXATION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Periprosthetic fracture
MAUDE report 24687466 ↗InjuryMar 18, 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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 24626968 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use 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 AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 24626579 ↗InjuryMar 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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 24598318 ↗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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 24597818 ↗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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Fungal Infection; Medical device site infection
MAUDE report 24591788 ↗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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 24512865 ↗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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 24465732 ↗InjuryFeb 18, 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. SURGEON PERFORMED WASHOUT AND SWAPPED COMPONENTS.THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Medical device site infection
MAUDE report 24383895 ↗InjuryFeb 18, 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 A FALL. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Periprosthetic fracture
MAUDE report 24381271 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24253752 ↗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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24147146 ↗InjuryJan 20, 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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24125505 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K161520. One submission often covers many models, so check the product and lot details in each record.
- Z-2425-2025 · Jul 11, 2025 · Open, ClassifiedELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
- Z-2424-2025 · Jul 11, 2025 · Open, ClassifiedELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
- Z-2423-2025 · Jul 11, 2025 · Open, ClassifiedELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
- Z-1857-2025 · Sep 22, 2024 · Open, ClassifiedELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
- Z-1881-2025 · Sep 1, 2023 · Open, ClassifiedSegmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03
- Z-1884-2025 · Sep 1, 2023 · Open, ClassifiedMale-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model
- Z-1882-2025 · Sep 1, 2023 · Open, ClassifiedSegmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, F
- Z-1879-2025 · Sep 1, 2023 · Open, Classifieda. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M,
- Z-2648-2017 · May 23, 2017 · TerminatedELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
- Z-2647-2017 · May 23, 2017 · TerminatedELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
- Z-2646-2017 · May 23, 2017 · TerminatedELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1217United 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 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 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 15-3817/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls5 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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