ELEOS™ 25002113ERecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI B27825002113E0), received between Sep 6, 2018 and May 20, 2026 — classified as 1 death, 28 injuries.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Unspecified Infection

  MAUDE report 24895703 ↗
• 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 AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 24701173 ↗
• InjuryJan 15, 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 AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24086999 ↗
• InjuryJan 13, 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 AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24063086 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RETROSPECTIVE INVESTIGATION, A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT REVISED ON (B)(6) 2023. THERE IS UNKNOWN INFORMATION ABOUT THE REVISION SURGERY, BUT AN MDR WILL BE REPORTED ON THE DEVICES EXPLANTED. THIS REPORT CAPTURES ELEOS AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23610820 ↗
• InjuryNov 18, 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 DISASSOCIATION OF ELEOS STEM EXTENSION FROM ELEOS RESURFACING FEMUR. THIS REPORT CAPTURES ELEOS AXIAL PIN BUT HAS NO ASSOCIATION TO THE REPORTED COMPLAINT.

  Patient problems: Joint Dislocation

  MAUDE report 23588853 ↗
• InjuryOct 17, 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 HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. COMPONENTS WASHOUT AND SWAPPED. THIS REPORT CAPTURES THE ELEOS AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23331293 ↗
• InjurySep 10, 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 17-YEAR-OLD MALE PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. WASH OUT AND SWAPPED COMPONENTS. THIS REPORT CAPTURES THE ELEOS AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23019949 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY T. STAMPER, AN ONKOS SALES REPRESENTATIVE, THAT A 75-YEAR-OLD FEMALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO A SUSPECTED PERI-OPERATIVE JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 20339831 ↗
• InjuryJul 25, 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 52-YEAR-OLD MALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY DUE TO A DISLOCATION OF THE TIBIAL HINGE AND TIBIAL POLY SPACER FROM THE TIBIAL BASEPLATE. THE REVISION WAS PERFORMED BY DOCTOR (B)(6) 2024.

  Patient problems: Joint Dislocation

  MAUDE report 19833414 ↗
• InjuryMay 9, 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 74-YEAR-OLD MALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE SURGEON, DOCTOR (B)(6) , WASHED OUT THE OPERATIVE JOINT AND REPLACED THE ELEOS DEVICES.

  Patient problems: Medical device site infection

  MAUDE report 19280202 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2023 FOR AN ALLEGED INFECTION. DURING THIS REVISION SURGERY AN ANTIBIOTIC SPACER WAS PLACED AND THE FOLLOWING IMPLANTS WERE EXPLANTED: ELEOS RESURFACING FEMUR AXIAL PIN SIZE: 3, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS TIBIAL POLY SPACER THICKNESS 12MM, ELEOS RESURFACING FEMUR SIZE: 3 RIGHT, ELEOS TIBIAL BASEPLATE SIZE: 4, AND ELEOS STEM EXTENSION CEMENTED 14X100MM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 17847970 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: POLY SPACER, TIBIAL HINGE COMPONENT, AND RESURFACING FEMUR AXIAL PIN. THE DATE OF THE PATIENT'S INDEX ELEOS SURGERY IS UNKNOWN AND THE IMPLANTS PLACED DURING THIS PROCEDURE ARE UNKNOWN. THEREFORE, IT IS UNKNOWN IF THERE WERE ADDITIONAL IMPLANTS AT THE TIME OF THIS PATIENT'S ALLEGED INFECTION. ATTEMPTS WERE MADE AND NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16966480 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 WHERE THE SURGEON REVISED THE FOLLOWING ELEOS IMPLANTS: RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S INDEX PROCEDURE: PROXIMAL TIBIA, SEGMENTAL STEM, RESURFACING FEMUR, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16255688 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 DUE TO AN ALLEGED INFECTION. THE PATIENT'S INDEX SURGERY OCCURED ON (B)(6) 2021 WHERE THE PATIENT WAS IMPLANTED WITH THE FOLLOWING IMPLANTS: ELEOS PROXIMAL TIBIA, ELEOS RESURFACING FEMUR AXIAL PIN, ELEOS POLY SPACER, ELEOS TIBIAL HINGE, ELEOS SEGMENTAL STEM, ELEOS STEM EXTENSION, AND ELEOS RESURFACING FEMUR. DURING THE REVISION PROCEDURE, THE ELEOS PROXIMAL TIBIA, ELEOS RESURFACING FEMUR AXIAL PIN, ELEOS POLY SPACER, AND ELEOS TIBIAL HINGE WERE REMOVED AND REPLACED. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY, AS THE PATIENT UNDERWENT A REVISION PROCEDURE. ALL THE DEVICES IMPLANTED AT THE TIME OF INFECTION WILL BE REPORTED. THIS REPORT CAPTURES THE ELEOS RESURFACING FEMUR AXIAL PIN.

  Patient problems: Unspecified Infection

  MAUDE report 15826513 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S MARGINS IN SOFT TISSUE WERE NOT CLEAR WHEN PATHOLOGY CAME BACK POST-OP AND THEREFORE A REVISION SURGERY WAS PERFORMED TO EXTEND THE RESECTION OF SOFT TISSUE AND REPLACE EASILY REPLACEABLE COMPONENTS. DURING THE REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS RESURFACING FEMUR AXIAL PIN SIZE 3, ELEOS TIBIAL HINGE WITH ROTATIONAL STOP, AND ELEOS TIBIAL POLY SPACER 16MM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13261710 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2021. THE FOLLOWING PARTS WERE REMOVED AND REVISED: RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THESE THREE IMPLANTS WERE ORIGINALLY PLACED ON (B)(6) 2021 DURING A REVISION SURGERY FOR AN ALLEGED INFECTION. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: RESURFACING FEMUR, CEMENTED STEM EXTENSION, CEMENTED SEGMENTAL STEM, PROXIMAL TIBIA, AND MALE-FEMALE MIDSECTION. THE SURGEON REMOVED IMPLANTS WITH POLY COMPONENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12217855 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. THE FOLLOWING PARTS WERE REMOVED AND REVISED: RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: RESURFACING FEMUR, CEMENTED STEM EXTENSION, AND TIBIAL BASEPLATE. THE SURGEON REMOVED IMPLANTS WITH POLY COMPONENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12189545 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION. THE FOLLOWING PARTS WERE REMOVED AND REVISED: RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: RESURFACING FEMUR, CEMENTED STEM EXTENSION, CEMENTED SEGMENTAL STEM, PROXIMAL TIBIA, AND MALE-FEMALE MIDSECTION. THE SURGEON REMOVED IMPLANTS WITH POLY COMPONENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12164243 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6) DUE TO THE PATIENT HAVING METALLOSIS. DURING THE SURGERY, THE SURGEON REMOVED ALL OF THE IMPLANTS THAT CONTAINED POLY COMPONENTS AND REPLACED THEM WITH NEW IMPLANTS. THE RESURFACING FEMUR AND TIBIAL BASEPLATE, WHICH ARE THE INTERFACING COMPONENTS WITH THE EXPLANTED IMPLANTS, WERE NOT EXPLANTED.

  Patient problems: Metal Related Pathology

  MAUDE report 11783091 ↗
• DeathJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DIED DUE TO AN ALLEGED INFECTION.

  Patient problems: Death

  MAUDE report 10150638 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10078912 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10078631 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A REVISION SURGERY DUE TO A DEEP LATE INFECTION. UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE RESURFACING FEMUR AND STEM EXTENSION DISSOCIATED.

  Patient problems: No Information; Unspecified Infection

  MAUDE report 9503706 ↗

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, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
• Z-2423-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
• Z-2424-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
• Z-1857-2025 · Sep 22, 2024 · Open, Classified
  ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
• Z-1879-2025 · Sep 1, 2023 · Open, Classified
  a. 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-1882-2025 · Sep 1, 2023 · Open, Classified
  Segmental 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-1881-2025 · Sep 1, 2023 · Open, Classified
  Segmental 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, Classified
  Male-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-2646-2017 · May 23, 2017 · Terminated
  ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
• Z-2648-2017 · May 23, 2017 · Terminated
  ELEOS 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 · Terminated
  ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E