ELEOSRecalls & reported problems across all models

We found 127 models of ELEOS by Onkos Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,661 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2018 and Jun 25, 2026 — classified as 29 deaths, 1,586 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (88 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

Most reported ELEOS problems

ELEOS models

127 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• ELEOS™ 25002111E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 deaths230 reports
• ELEOS™ 25001208E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  3 deaths193 reports
• ELEOS™ THSMWRS01M

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  190 reports
• ELEOS™ 25000007E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  1 death86 reports
• ELEOS™ 25002100E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  4 deaths83 reports
• ELEOS™ 25000009E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  2 deaths73 reports
• ELEOS™ 25001040E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 deaths68 reports
• ELEOS™ 25001210E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  43 reports
• ELEOS™ 25001212E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  33 reports
• ELEOS™ 25001220E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  30 reports
• ELEOS™ 25002113E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 death29 reports
• ELEOS™ 25001216E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 death26 reports
• ELEOS™ PF-2000L-02M

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  25 reports
• ELEOS™ 25002101E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  24 reports
• ELEOS™ 25002112E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  22 reports
• ELEOS™ PF-2000R-02M

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  22 reports
• ELEOS™ PT-20000-02M

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  22 reports
• ELEOS™ 25002114E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  20 reports
• ELEOS™ 25001070E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  18 reports
• ELEOS™ 25001050E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  17 reports
• ELEOS™ 25002203E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  3 deaths17 reports
• ELEOS™ KSC01530E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 deaths17 reports
• ELEOS™ 25001060E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 death12 reports
• ELEOS™ 2500R002E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  12 reports
• ELEOS™ 25001090E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  11 reports
• ELEOS™ 25002202E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  11 reports
• ELEOS™ 25002204E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  1 death10 reports
• ELEOS™ KSC16100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 deaths10 reports
• ELEOS™ 25001110E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  9 reports
• ELEOS™ 25001140E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  9 reports
• ELEOS™ 25000011E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  8 reports
• ELEOS™ 2500R003E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 death8 reports
• ELEOS™ KSC01665E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  8 reports
• ELEOS™ KSC12100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  8 reports
• ELEOS™ KSC18100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  8 reports
• ELEOS™ 25002200E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  7 reports
• ELEOS™ 25002201E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  7 reports
• ELEOS™ KSP14100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  7 reports
• ELEOS™ KSP16140E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  7 reports
• ELEOS™ 2500L003E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  6 reports
• ELEOS™ 2500L004E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  6 reports
• ELEOS™ KSC01265E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  6 reports
• ELEOS™ KSC01465E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  6 reports
• ELEOS™ KSP13140E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  6 reports
• ELEOS™ 25000001E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  5 reports
• ELEOS™ 25000013E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  5 reports
• ELEOS™ 25002205E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  5 reports
• ELEOS™ 2500L002E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  5 reports
• ELEOS™ 26000026E

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  5 reports
• ELEOS™ 26012804E

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  5 reports
• ELEOS™ KPONTP32E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• ELEOS™ KSP13100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• ELEOS™ KSP15140E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• ELEOS™ KSP17100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• ELEOS™ KTAGB305E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• ELEOS™ MS-070MM-02M

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  5 reports
• ELEOS™ 25004013E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  4 reports
• ELEOS™ KSP11100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  4 reports
• ELEOS™ KSP12100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  4 reports
• ELEOS™ KSP17140E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  4 reports
• ELEOS™ KTAGB410E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  4 reports
• ELEOS™ 2500R004E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• ELEOS™ 26012802E

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  3 reports
• ELEOS™ KPONTP35E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• ELEOS™ KSC01065E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• ELEOS™ KSC14100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• ELEOS™ KSP11140E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• ELEOS™ KTAGB315E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• ELEOS™ MS-040MM-02M

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• ELEOS™ SI-7501E-03N

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• ELEOS™ 25000041E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• ELEOS™ 25000051E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• ELEOS™ 25004009E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• ELEOS™ 25004011E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• ELEOS™ 2500BP14E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• ELEOS™ 2500BP20E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• ELEOS™ 2500SP12E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• ELEOS™ 2500SP14E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  2 reports
• ELEOS™ 2500SP16E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  2 reports
• ELEOS™ 26010003E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• ELEOS™ 26012801E

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• ELEOS™ 26012803E

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• ELEOS™ KSC01500E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KSP10100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KSP12140E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KSP14140E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KSP15100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KSP16100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KSP18140E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KSP20100E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KTAGB105E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KTAGB110E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KTAGB205E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KTAGB210E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KTAGB505E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ KTAGB510E

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• ELEOS™ SPSE0004E

  PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
  2 reports
• ELEOS™ 25000071E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report
• ELEOS™ 2500BP12E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report
• ELEOS™ 2500BP22E

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report

Recent ELEOS adverse event reports

The 15 most recent reports across all models, 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 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 AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25621637 ↗
• 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 POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25621634 ↗
• InjuryJun 25, 2026Adverse 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 AN ALLEGED DISLOCATION. SURGEON SHORTENED ELEOS MALE-MALE MIDSECTION FROM 70MM TO 40MM. THIS REPORT CAPTURES ELEOS MALE-MALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25620506 ↗
• 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 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 55-YEAR-OLD MALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION ON (B)(6) 2026 DUE TO LOOSENING OF THE FEMORAL STEM. PATIENT WAS EXPERIENCING PAIN AT THE KNEE, SURGEON REPLACED STEM COMPONENT. THIS REPORT CAPTURES ELEOS STEM EXTENSION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening

  MAUDE report 25457354 ↗
• 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 AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25457129 ↗
• 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 POLY SPACER (RIGHT). THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25302913 ↗
• 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 AXIAL PIN (RIGHT). THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25302911 ↗
• 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 POLY SPACER (LEFT). THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25302908 ↗
• 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 AXIAL PIN (LEFT). THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25302906 ↗
• 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 POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25229967 ↗
• 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 AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25229966 ↗

Other Onkos Surgical, Inc. products

• ELEOS Limb Salvage System48 models · 236 reports
• ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY4 models · 63 reports
• My3D Personalized Pelvic Reconstruction20 models · 52 reports
• ELEOS Limb Salvage System With BioGrip10 models · 44 reports