ELEOS Limb Salvage System With BioGripRecalls & reported problems across all models
Onkos Surgical, Inc. · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls
- 0
We found 10 models of ELEOS Limb Salvage System With BioGrip by Onkos Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2021 and May 28, 2026 — classified as 41 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 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 With BioGrip problems
Device problems
- Adverse Event Without Identified Device or Use Problem33
- Improper or Incorrect Procedure or Method4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Insufficient Device Problem Information2
- Loss of or Failure to Bond1
- Unintended Movement1
- Unstable1
- Use of Device Problem1
Patient problems
- Unspecified Infection16
- Insufficient Information8
- Aseptic loosening6
- Medical device site infection6
- Loss of Range of Motion4
- Scar Tissue4
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
ELEOS Limb Salvage System With BioGrip models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ELEOS Limb Salvage System With BioGrip HC-11120-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- ELEOS Limb Salvage System With BioGrip HC-15120-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- ELEOS Limb Salvage System With BioGrip HC-17120-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- ELEOS Limb Salvage System With BioGrip HC-13120-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- ELEOS Limb Salvage System With BioGrip PB-2800R-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- ELEOS Limb Salvage System With BioGrip PB-3200R-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- ELEOS Limb Salvage System With BioGrip PB-2400R-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- ELEOS Limb Salvage System With BioGrip HC-09100-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- ELEOS Limb Salvage System With BioGrip PB-3600R-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- ELEOS Limb Salvage System With BioGrip HC-10100-03MPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent ELEOS Limb Salvage System With BioGrip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT AN 81-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION ON (B)(6) 2026 DUE TO LOOSENING OF THE FEMORAL 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
MAUDE report 25318158 ↗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 HA COLLAR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Periprosthetic fracture
MAUDE report 24381245 ↗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 SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Periprosthetic fracture
MAUDE report 24381244 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY (B)(4), AN ONKOS SALES REPRESENTATIVE, THAT A 59-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO LOOSENING OF SEGMENTAL 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
MAUDE report 23687660 ↗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 LOOSENING OF THE SEGMENTAL STEM AND COLLAR. CEMENT DID NOT BOND TO STEM AND NO GROWTH ON COLLAR. THIS REPORT CAPTURES ELEOS HA COLLAR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Aseptic loosening
MAUDE report 23673952 ↗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 LOOSENING OF THE SEGMENTAL STEM AND COLLAR. CEMENT DID NOT BOND TO STEM AND NO GROWTH ON COLLAR. THIS REPORT CAPTURES ELEOS CEMENTED STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Aseptic loosening
MAUDE report 23673951 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY D. HARDARDT, AND ONKOS SALES REPRESENTATIVE THAT A 33-YEAR-OLD MALE PATIENT WITH AN ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY AND NEEDED A CHANGE IN CONSTRUCT. CONVERTED THEIR RESURFACING FEMUR WITH PTR TO A DTR/PTR. REVISED ELEOS STEM FOR LOOSENING IN TIBIA. THIS REPORT CAPTURES THE ELEOS CANAL FILLING SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Aseptic loosening
MAUDE report 22890797 ↗InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ONKOS SALES REPRESENTATIVE REPORTED A REVISION SURGERY WHICH TOOK PLACE ON (B)(6) 2025 DUE TO AN ALLEGED PERIPROSTHETIC JOINT INFECTION IN AN 85-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT.
Patient problems: Medical device site infection
MAUDE report 21979057 ↗InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ONKOS SALES REPRESENTATIVE REPORTED A REVISION SURGERY WHICH TOOK PLACE ON (B)(6) 2025 DUE TO AN ALLEGED PERIPROSTHETIC JOINT INFECTION IN AN 85-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT.
Patient problems: Medical device site infection
MAUDE report 21979054 ↗InjuryDec 26, 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 70-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION ON (B)(6) 2024 DUE TO LOOSENING OF THE ELEOS CANAL FILLING SEGMENTAL STEM THAT WAS INSERTED INTO THE FEMUR.
Patient problems: Aseptic loosening
MAUDE report 21020744 ↗InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY (B)(4), AN ONKOS DISTRIBUTOR, THAT A 43-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF THE ELEOS CEMENTED SEGMENTAL STEM THAT WAS INSERTED INTO THE FEMUR WITHOUT THE USE OF BONE CEMENT. THE REPORTED INFORMATION ALSO INDICATED THAT THE ELEOS TIBIAL BASEPLATE WAS ALSO INSERTED WITHOUT BONE CEMENT AND THE SURGEON SUSPECTED THAT THE PATIENT HAD A PERI-OPERATIVE INFECTION.
Patient problems: Medical device site infection
MAUDE report 20476291 ↗InjuryOct 17, 2024Loss of or Failure to Bond; Unstable; Loss of or Failure to Bond; Unstable
IT WAS REPORTED BY (B)(4), AN ONKOS DISTRIBUTOR, THAT A 43-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF THE ELEOS CEMENTED SEGMENTAL STEM THAT WAS INSERTED INTO THE FEMUR WITHOUT THE USE OF BONE CEMENT. THE REPORTED INFORMATION ALSO INDICATED THAT THE ELEOS TIBIAL BASEPLATE WAS ALSO INSERTED WITHOUT BONE CEMENT AND THE SURGEON SUSPECTED THAT THE PATIENT HAD A PERI-OPERATIVE INFECTION.
Patient problems: Joint Laxity; Medical device site infection
MAUDE report 20475665 ↗InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY (B)(6), AN ONKOS DISTRIBUTOR, THAT A 34-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT AND CUSTOM PROXIMAL TIBIA UNDERWENT A REVISION SURGERY ON (B)(6) 2024 TO REMOVE ALL IMPLANTED HARDWARE AND PERFORM AN ABOVE THE KNEE AMPUTATION THE OPERATIVE LEG DUE TO A CHRONIC INFECTION.
Patient problems: Medical device site infection
MAUDE report 19378101 ↗InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY (B)(6), AN ONKOS DISTRIBUTOR, THAT A 34-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT AND CUSTOM PROXIMAL TIBIA UNDERWENT A REVISION SURGERY ON (B)(6) 2024 TO REMOVE ALL IMPLANTED HARDWARE AND PERFORM AN ABOVE THE KNEE AMPUTATION THE OPERATIVE LEG DUE TO A CHRONIC INFECTION.
Patient problems: Medical device site infection
MAUDE report 19378098 ↗InjuryFeb 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT SUFFERED FROM LOOSENING OF THE FEMORAL 17X100MM CEMENTED SEGMENTAL STEM AND ASSOCIATED REDUCED RESECTION COLLAR. THE REVISION SURGERY WAS PERFORMED BY DOCTOR (B)(6) ON (B)(6) 2023. ON 20 FEBRUARY 2024 AND 21 FEBRUARY 2024, ADDITIONAL DETAILS REGARDING THE PRIMARY SURGERY AND PATIENT INFORMATION WERE REQUESTED. ON 21 FEBRUARY 2024, (B)(6) CONFIRMED THAT ADDITIONAL DETAILS WITH RESPECT TO THE PRIMARY SURGERY AND PATIENT INFORMATION REMAIN UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 18769231 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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