ELEOS™ 25001140ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI B27825001140E0), received between Sep 8, 2021 and Dec 23, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Adverse 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 65-YEAR-OLD FEMALE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT UNDERWENT REVISION DUE TO AN ALLEGED INFECTION. ALL COMPONENTS BUT THE TIBIAL BASEPLATE AND TIBIAL STEM WERE SWAPPED. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23881865 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY P. MEDINA, AN ONKOS SALES REPRESENTATIVE, THAT A 32-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO AN ALLEGED PERI-OPERATIVE INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 20789699 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY SAVANNAH BOYD, AN ONKOS DISTRIBUTOR, THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS AN ALLEGED INFECTION. THE SURGERY TOOK PLACE ON (B)(6) 2024 AND IS THE SECOND REVISION SURGERY FOR THIS PATIENT IN WHICH ELEOS DEVICES WERE REVISED. AT THE TIME OF THIS REVISION SURGERY, THE THEN 55-YEAR-OLD FEMALE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT HAD NINE (9) ELEOS COMPONENTS EXPLANTED AND REPLACED EXCEPT FOR THE FEMORAL HEAD WHICH WAS REPLACED WITH A NON-ONKOS DEVICE.

  Patient problems: Medical device site infection

  MAUDE report 18989351 ↗
• InjuryDec 16, 2022Adverse 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 FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, TWO MALE-FEMALE MIDSECTIONS, TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL 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 15996384 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE FOLLOWING IMPLANTS WERE REVISED DURING THE REVISION: ELEOS MALE-FEMALE MIDSECTION, ELEOS MALE-FEMALE MIDSECTION, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ROTATIONAL STOP, ELEOS TIBIAL POLY SPACER AND ELEOS DISTAL FEMUR.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15982691 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF MOBILITY IN THEIR KNEE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION SURGERY, THE SURGEON IDENTIFIED SCAR TISSUE FORMATION. THE SURGEON REMOVED THE SCAR TISSUE. THE SURGEON TOOK OUT ALL OF THE IMPLANTS BESIDES THE SEGMENTAL STEM, COLLAR, LOCKING RING, AND TIBIAL BASEPLATE, AND FLASHED THESE DEVICES THEN RE-IMPLANTED THE DEVICES. THE SURGEON SCHEDULED ANOTHER REVISION SURGERY ON (B)(6) 2022 IN ORDER TO REVISE SOME IMPLANTS AND PERFORM A WASHOUT IN ORDER TO PREVENT AN INFECTION. ON (B)(6) 2022, THE SURGEON REVISED THE FOLLOWING IMPLANTS: DISTAL FEMUR AXIAL PIN, POLY SPACER, TIBIAL HINGE COMPONENT, DISTAL FEMUR, AND MALE-FEMALE MIDSECTION. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 15677482 ↗
• InjuryApr 27, 2022Adverse 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 TO WASHOUT THEIR PROXIMAL FEMORAL REPLACEMENT SYSTEM. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY TO WASHOUT THEIR DISTAL FEMORAL REPLACEMENT SYSTEM AND REVISE THE TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL FEMUR AXIAL PIN. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY WHERE ALL IMPLANTS WERE REVISED. THE FOLLOWING IMPLANTS WERE REVISED: MALE-MALE MIDSECTION, MALE-FEMALE MIDSECTION, POLY SPACER, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, PROXIMAL FEMUR, AND DISTAL FEMUR. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 14229011 ↗
• InjurySep 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6). THE SURGERY WAS PERFORMED DUE TO ULCERATION AROUND ELEOS TOTAL FEMUR COMPONENT. DURING THE SURGERY, THE SURGEON REMOVED ALL IMPLANTS THAT WERE IMPLANTED AT THE TIME AS IT WAS DECIDED THAT THE PATIENT'S LEG WOULD BE AMPUTATED ABOVE THE KNEE. TO GIVE THE PATIENT'S THIGH STRUCTURE, A MALE-FEMALE MIDSECTION WITH A CUSTOM END CAP IMPLANT WAS PLACED IN THE PATIENT'S UPPER LEG.

  Patient problems: Ulcer

  MAUDE report 12441357 ↗
• InjurySep 8, 2021Patient-Device Incompatibility

  A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6). THE SURGERY WAS PERFORMED DUE TO THE SEGMENT BEING TOO LONG AFTER SURGERY AND SHORTENING WAS REQUIRED. THERE WAS NO REPORT THAT THE ELEOS COMPONENT FAILED OR CONTRIBUTED TO THE REVISION. DURING THE SURGERY, THE SURGEON REMOVED A 140MM MALE-FEMALE MIDSECTION AND A CUSTOM END CAP IMPLANT MANUFACTURED BY MICROPORT AND PLACED A 90MM MALE-FEMALE MIDSECTION. HE THEN REPLACED THE CUSTOM END CAP. IT IS UNKNOWN WHAT CAUSED THE SEGMENT TO BE TOO LONG FOR THE PATIENT.

  Patient problems: Pain

  MAUDE report 12439290 ↗

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-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-2425-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. 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-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-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-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-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