ELEOS™ 25001070ERecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI B27825001070E0), received between Aug 2, 2018 and Jul 10, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ELEOS PROXIMAL FEMURE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION THIS REPORT CAPTURES THE ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION SURGERY.

  Patient problems: Medical device site infection

  MAUDE report 22469712 ↗
• InjuryOct 23, 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 AN ALLEGED PERI-OPERATIVE INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 20517575 ↗
• InjuryAug 20, 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 16-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO A POSSIBLE INFECTION WHICH IS BELIEVED TO BE PREVENTING THE PATIENT'S WOUND FROM HEALING.

  Patient problems: Medical device site infection

  MAUDE report 20007325 ↗
• InjuryMay 22, 2024Adverse 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 AN 18-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT INCLUDING AN ELEOS PROXIMAL TIBIA 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 LISTED ABOVE.

  Patient problems: Medical device site infection

  MAUDE report 19373645 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS IDENTIFIED THAT A PATIENT RECEIVED A REVISION PROCEDURE TO REMOVE AND REPLACE AN ELEOS PROXIMAL FEMUR, ELEOS MALE-FEMALE MIDSECTION, AND AN ELEOS SEGMENTAL STEM. THE REASON FOR REVISION IS UNKNOWN AT THIS TIME. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES THE REVISED ELEOS MALE-FEMALE MIDSECTION.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 19325995 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WILL BE REVISED DUE TO AN ALLEGED INFECTION. THE FOLLOWING IMPLANTS WILL BE REVISED: ELEOS PROXIMAL FEMUR, ELEOS MALE-FEMALE MIDSECTION, AND ELEOS CEMENTED SEGMENTAL STEM. THE DATE OF THE REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY, AS THE IMPLANTED DEVICES WILL BE REVISED. THIS REPORT CAPTURES THE ELEOS MALE-FEMALE MIDSECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19281844 ↗
• InjuryJun 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: DISTAL FEMUR AXIAL PIN, TIBIAL POLY SPACER, DISTAL FEMUR, AND TIBIAL HINGE COMPONENT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: STEM EXTENSION, MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17153468 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER, ELEOS DISTAL FEMUR AXIAL PIN AND ELEOS DISTAL FEMUR. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CANAL-FILLING STEM EXTENSION, TIBIAL BASEPLATE, MALE-FEMALE MIDSECTIONS, MALE-MALE MIDSECTION, AND PROXIMAL FEMUR. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16482878 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2023 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER AND ELEOS DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 16297118 ↗
• InjuryJun 9, 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: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, DISTAL FEMUR, MALE-FEMALE MIDSECTION, AND POLY SPACER. THE FOLLOWING IMPLANTS REMAIN IMPLANTED: CEMENTED SEGMENTAL STEM, TIBIAL BASEPLATE, AND CEMENTED STEM EXTENSION. MULTIPLE ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 14649551 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SCHEDULED A REVISION SURGERY ON (B)(6) 2022 FOR A POLY SWAP AFTER HAVING A DISTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2021. THE REVISION SURGERY WAS CANCELLED AND HAS NOT BEEN RESCHEDULED. IT WAS CANCELLED DUE TO ALLEGED PATIENT ILLNESS. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13447777 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SCHEDULED A REVISION SURGERY ON (B)(6) 2022 FOR A POLY SWAP AFTER HAVING A DISTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2021. THE REVISION SURGERY WAS CANCELLED AND HAS NOT BEEN RESCHEDULED. IT WAS CANCELLED DUE TO ALLEGED PATIENT ILLNESS. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13447635 ↗
• InjuryDec 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE PATIENT FELL FOR AN UNKNOWN REASON WHICH CAUSED SOFT TISSUE DAMAGE TO THE SURROUNDING STRUCTURES OF THE KNEE. DURING THE REVISION SURGERY, THE SURGEON PERFORMED A SOFT TISSUE REPAIR. A SEGMENTAL STEM WAS REQUESTED FOR THE REVISION SURGERY BUT WAS NOT IMPLANTED. NO ELEOS IMPLANTS WERE REVISED DURING THE REVISION SURGERY. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN MADE AVAILABLE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 13011495 ↗
• InjuryAug 4, 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 PATIENT HAD FALLEN AND IT CAUSED AN OPEN SORE ON THEIR LEFT HIP. THE PATIENT LAID WITH AN OPEN WOUND FOR APPROXIMATELY TWO WEEKS. DURING THE REVISION SURGERY, THE SURGEON PERFORMED HEAVY INCISION AND DRAINAGE AND PERFORMED A BIPOLAR EXCHANGE FOR INFECTION CONTROL. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY ON (B)(6) 2020: ELEOS PROXIMAL FEMUR (98MM), ELEOS MALE-FEMALE MIDSECTION (110MM), ELEOS MALE-FEMALE MIDSECTION (70MM), AND ELEOS CEMENTED STEM (15X120MM). THE FOLLOWING IMPLANTS WERE REVISED DURING THE REVISION SURGERY: ELEOS FEMORAL HEAD (36MM, +0MM TAPER) AND A MICROPORT GLADIATOR BIPOLAR SHELL (56MM). NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 12273481 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem

  A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6) DUE TO JOINT STIFFNESS OF THE KNEE WHICH LED TO DECREASED RANGE OF MOTION. THE SALES REPRESENTATIVE STATED THAT THE SURGEON BELIEVED THAT THE PATIENT WAS NONCOMPLIANT WITH HER REHABILITATION. A 70MM MALE-FEMALE MIDSECTION THAT WAS PLACED DURING THE PRIMARY SURGERY, WHICH TOOK PLACE ON (B)(6) 2020, WAS EXPLANTED, AND REPLACED WITH A 60MM MALE-FEMALE MIDSECTION. THIS WAS DONE TO INCREASE THE RANGE OF MOTION OF THE KNEE. AN 8MM POLY SPACER WAS EXPLANTED DURING THE REVISION WHICH WAS PLACED DURING THE PRIMARY SURGERY. THIS WAS REPLACED WITH A 12MM POLY SPACER. DURING THE REVISION, THE DISTAL FEMUR COMPONENT, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN.

  Patient problems: Loss of Range of Motion

  MAUDE report 11603551 ↗
• InjuryFeb 25, 2021Adverse 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 11382093 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH A LUMP ON THEIR KNEE, WHICH WAS SUSPECTED TO BE CAUSED BY AN INFECTION. A REVISION SURGERY WAS PERFORMED TO DRAIN AND IRRIGATE THE KNEE. UPON REMOVING THE POLY COMPONENTS, THE SURGEON OBSERVED THAT THE CEMENTED STEM WAS LOOSE. THE SURGEON WASHED THE FEMORAL INTRAMEDULLARY CANAL AND PLACED NEW COMPONENTS WITHOUT CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 7855620 ↗
• InjuryAug 2, 2018Adverse 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 7742517 ↗

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-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-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-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-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
• 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