ELEOS Limb Salvage SystemRecalls & reported problems across all models
Onkos Surgical, Inc. · 48 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 236
- Deaths reported
- 3
- Injuries reported
- 216
- Recalls
- 0
We found 48 models of ELEOS Limb Salvage System by Onkos Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 236 adverse event reports in the FDA's MAUDE database, received between May 23, 2019 and Jun 26, 2026 — classified as 3 deaths, 216 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (15 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ELEOS Limb Salvage System problems
Device problems
- Adverse Event Without Identified Device or Use Problem179
- Loosening of Implant Not Related to Bone-Ingrowth15
- Insufficient Device Problem Information14
- Device Damaged Prior to Receipt by User7
- Fracture5
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated3
- Loose or Intermittent Connection3
Patient problems
- Unspecified Infection103
- Insufficient Information46
- Medical device site infection31
- Fall14
- No Clinical Signs, Symptoms or Conditions10
- Aseptic loosening9
- Pain8
- Joint Laxity6
ELEOS Limb Salvage System models
48 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ELEOS™ Limb Salvage System THSMWOS01MProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer25 reports
- ELEOS Limb Salvage System CS-13120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented15 reports
- ELEOS™ Limb Salvage System TB-2203E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER13 reports
- ELEOS Limb Salvage System CS-15120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 death10 reports
- ELEOS Limb Salvage System CS-17120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 death10 reports
- ELEOS Limb Salvage System HR-30001-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- ELEOS™ Limb Salvage System TB-2202E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- ELEOS Limb Salvage System HR-30000-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- ELEOS™ Limb Salvage System TB-TSCRW-01MProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer8 reports
- ELEOS Limb Salvage System CB-15152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 death7 reports
- ELEOS Limb Salvage System FS-14120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented7 reports
- ELEOS Limb Salvage System FB-11152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented6 reports
- ELEOS Limb Salvage System FB-16152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented6 reports
- ELEOS Limb Salvage System FS-12120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented6 reports
- ELEOS™ Limb Salvage System TB-2204E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- ELEOS Limb Salvage System CS-11120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5 reports
- ELEOS Limb Salvage System FS-11120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5 reports
- ELEOS Limb Salvage System FS-13120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5 reports
- ELEOS Limb Salvage System FS-15120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5 reports
- ELEOS Limb Salvage System FS-21120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5 reports
- ELEOS™ Limb Salvage System TB-2205E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- ELEOS Limb Salvage System CB-11152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented4 reports
- ELEOS Limb Salvage System FB-15152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented4 reports
- ELEOS Limb Salvage System FB-17152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented4 reports
- ELEOS™ Limb Salvage System RF-TSCRW-01MProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer4 reports
- ELEOS™ Limb Salvage System 001-03-00021TRAY, SURGICAL, INSTRUMENT3 reports
- ELEOS Limb Salvage System CB-13152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented3 reports
- ELEOS Limb Salvage System FS-17120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented3 reports
- ELEOS Limb Salvage System FS-20120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented3 reports
- ELEOS™ Limb Salvage System RF-L002E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- ELEOS™ Limb Salvage System RF-R002E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- ELEOS Limb Salvage System SB-4044V-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- ELEOS™ Limb Salvage System TB-2201E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- ELEOS Limb Salvage System CS-09100-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- ELEOS Limb Salvage System FB-19152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- ELEOS Limb Salvage System FS-16120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- ELEOS Limb Salvage System FS-18120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- ELEOS Limb Salvage System FS-19120-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- ELEOS™ Limb Salvage System RF-R004E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ELEOS™ Limb Salvage System CB-11255-03MProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- ELEOS Limb Salvage System CS-10100-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- ELEOS Limb Salvage System FB-12152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- ELEOS Limb Salvage System FB-13152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- ELEOS Limb Salvage System FB-14152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- ELEOS Limb Salvage System FB-21152-03MProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- ELEOS™ Limb Salvage System RF-L003E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ELEOS™ Limb Salvage System RF-L004E-01MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ELEOS Limb Salvage System SB-3640V-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent ELEOS Limb Salvage System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO A STEM FRACTURE. IT WAS REPORTED THAT PATIENT STARTED HAVING HIP PAIN FIVE WEEKS PRIOR TO SURGERY. THIS REPORT CAPTURES ELEOS FEMORAL STEM.
Patient problems: External Prosthetic Device Pain; Periprosthetic fracture
MAUDE report 25636452 ↗InjuryJun 10, 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 25457131 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED ON (B)(6) 2025 AND PRESENTED EVIDENCE OF LOOSENING AROUND THE FEMORAL STEM.
Patient problems: Aseptic loosening
MAUDE report 25325136 ↗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 BASEPLATE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 25160806 ↗InjuryMay 1, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 67-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION ON (B)(6) 2026 DUE TO LOOSENING. PATIENT FELL AND STEM. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Aseptic loosening; Fall
MAUDE report 25057501 ↗InjuryApr 21, 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 24940591 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 60-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION ON (B)(6) 2026 DUE TO LOOSENING THAT'S BEEN OCCURRING OVERTIME. SURGEON REVISED FOR BETTER FIXATION. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Aseptic loosening
MAUDE report 24800520 ↗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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24701921 ↗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 SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Periprosthetic fracture
MAUDE report 24687458 ↗InjuryMar 23, 2026Loss of Osseointegration
IT HAS BEEN REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT A PATIENT WITH ELEOS PROXIMAL TIBIAL REPLACEMENT REVISION DATE ON (B)(6) 2026. REPRTED THAT FEMUR WAS REVISED DUE TO PATELLAR TRACKING IN ADDITION TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THIS REPORT CAPTURES ELEOS RESURFACING FEMUR AS SERIOUS INJURY.
Patient problems: Aseptic loosening
MAUDE report 24663384 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A FRACTURE. THIS REPORT CAPTURES ELEOS FEMORAL STEM.
Patient problems: Periprosthetic fracture
MAUDE report 24550731 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO A FRACTURE. THIS REPORT CAPTURES ELEOS FEMORAL STEM.
Patient problems: Periprosthetic fracture
MAUDE report 24549173 ↗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 BASEPLATE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 24465733 ↗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 TAPERED SCREW. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 24465729 ↗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 SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 24465703 ↗
Other Onkos Surgical, Inc. products
All Onkos Surgical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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