ELEOS™ 25001110ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI B27825001110E0), received between Sep 11, 2020 and Nov 28, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 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.

• InjuryNov 28, 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 PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. 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 23673912 ↗
• InjuryJul 3, 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 70-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR & PROXIMAL TIBIA REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE SURGEON, DOCTOR MAALE, WASHED OUT THE OPERATIVE JOINT AND REPLACED THE ELEOS DEVICES.

  Patient problems: Medical device site infection

  MAUDE report 19671983 ↗
• 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 16482877 ↗
• 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 16297115 ↗
• InjuryNov 18, 2021Adverse 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 AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, DISTAL FEMUR, TIBIAL HINGE COMPONENT, POLY SPACER, 50MM MALE-FEMALE MIDSECTION, AND 110MM MALE-FEMALE MIDSECTION. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CEMENTED BOWED STEM, TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION. NO FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12840225 ↗
• 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 12273480 ↗
• 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 11382100 ↗
• MalfunctionOct 6, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT UNDERWENT A REVISION SURGERY (B)(6) 2020 PERFORMED BY (B)(6) DUE TO DISSOCIATION OF THE DISTAL FEMUR COMPONENT AND A MALE-FEMALE MIDSECTION THAT CONNECTED TO THE SEGMENTAL STEM. THE SURGEON BELIEVED THAT RAISING THE JOINT LINE AND SHORTENING THE LIMB CAUSED INCREASED MECHANICAL FORCES ON THE COMPONENTS, WHICH LED TO THE DISSOCIATION. THE SURGEON LOWERED THE JOINT LINE AND INCREASED THE LIMB LENGTH BACK TO NORMAL. THE PATIENT'S PROXIMAL TIBIA COMPONENT, DISTAL FEMUR COMPONENT, AND TIBIAL HINGE COMPONENT WERE EXPLANTED AND REVISED ON (B)(6) 2020. THE PATIENT'S 10MM TIBIAL POLY SPACER WAS EXPLANTED AND REPLACED WITH AN 8MM TIBIAL POLY SPACER ON (B)(6) 2020. A 140MM MALE-FEMALE MIDSECTION, A 70MM MALE-FEMALE MIDSECTION, AND A 50 MALE-FEMALE MIDSECTION WERE PLACED ON (B)(6) 2020 TO REPLACE A 90MM MALE-FEMALE MIDSECTION, TWO 40MM MALE-FEMALE MIDSECTIONS, AND A 100MM MALE-FEMALE MIDSECTION.

  Patient problems: Insufficient Information

  MAUDE report 10634924 ↗
• InjurySep 11, 2020Appropriate Device Problem Term/Code Not Available

  A PATIENT UNDERWENT A REVISION SURGERY PERFORMED BY (B)(6) ON (B)(6) 2020 AT (B)(6) DUE TO AN INFECTION. THE PATIENT UNDERWENT AN INCISION AND DRAINAGE PROCEDURE IN AN ATTEMPT TO CLEAN THE INFECTED AREA. A NEW MIDSECTION AND SEGMENTAL STEM WERE PLACED AFTER EXPLANTING THE PREVIOUSLY IMPLANTED COMPONENTS TO FACILITATE REMOVAL OF THE INFECTION. THE MIDSECTION THAT WAS PLACED DURING THE PREVIOUS REVISION SURGERY WAS 110MM IN LENGTH AND IT WAS REPLACED WITH A 140MM MIDSECTION. THIS WAS DONE FOR AN UNKNOWN REASON.

  Patient problems: Unspecified Infection

  MAUDE report 10520820 ↗

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