ELEOS™ 2500R003ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI B2782500R003E0), received between Sep 6, 2018 and Nov 18, 2025 — classified as 1 death, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 DISSASOCIATION OF STEM EXTENSION FROM FEMUR. THIS REPORT CAPTURES ELEOS RESURFACING FEMUR THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 23588858 ↗
• 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 17847990 ↗
• 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 16255674 ↗
• 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.

  Patient problems: Unspecified Infection

  MAUDE report 15826300 ↗
• 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 12189531 ↗
• 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 ORGIINAL 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 12164250 ↗
• 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 10150637 ↗
• InjurySep 6, 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, WHERE ALL ELEOS COMPONENTS WERE REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 7851168 ↗

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-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-2423-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. 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-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-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-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-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-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-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