ELEOS™ 25001210ERecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI B27825001210E0), received between Jun 18, 2018 and Jun 25, 2026 — classified as 43 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 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 POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25621634 ↗
• 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 POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25229967 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO PATELLA BAJA. PATIENT'S PATELLA WAS REPORTED TO BE LOWER THAN IT SHOULD BE AND SLIGHTLY DISLOCATING. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25160809 ↗
• InjuryFeb 3, 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 POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24253754 ↗
• 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 POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24086990 ↗
• InjuryDec 23, 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 AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23878675 ↗
• InjuryNov 21, 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. PATIENT DISLOCATED THEIR KNEE. ONLY THE POLY SPACER WAS SWAPPED AND REVISED. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 23616998 ↗
• InjuryNov 19, 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 AN ALLEGED INFECTION. SURGEON SWAPPED MODULAR COMPONENTS. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23594063 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ONKOS SALES REPRESENTATIVE REPORTED THAT A PATIENT WITH AN ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 22137110 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HISTORICAL REVISION OF AN ELEOS DISTAL FEMUR REPLACEMENT WAS REPORTEDLY DUE TO AN ALLEGED PERI-PROSTHETIC JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 22063531 ↗
• InjuryMar 27, 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 58-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR AND PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21713546 ↗
• InjuryNov 26, 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 57-YEAR-OLD FEMALE 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 20784261 ↗
• InjurySep 30, 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 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 20338255 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A. ROMBERGER, AN ONKOS SALES REPRESENTATIVE, THAT A 67-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE SURGEON, DOCTOR WODOWSKI, WASHED OUT THE OPERATIVE JOINT AND REPLACED THE ELEOS DEVICES LISTED ABOVE.

  Patient problems: Medical device site infection

  MAUDE report 19623197 ↗
• 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 A 78-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 MALE, WASHED OUT THE OPERATIVE JOINT AND REPLACED THE ELEOS DEVICES LISTED ABOVE.

  Patient problems: Medical device site infection

  MAUDE report 19373462 ↗
• InjuryFeb 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  ON 05 JANUARY 2024, B. STEINKAMP (AN ONKOS DISTRIBUTOR) REPORTED THAT A 77-YEAR-OLD MALE PATIENT WHO HAD ALLEGEDLY SUFFERED FROM INSTABILITY IN THE KNEE JOINT INVOLVING A PREVIOUSLY IMPLANTED ELEOS HINGE KNEE REPLACEMENT, UNDERWENT A REVISION SURGERY TO REPLACE THE 10MM TIBIAL POLY SPACER WITH A 20MM TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS WERE ALSO REPLACED AS PART OF THIS REVISION: TIBIAL HINGE W/ ROTATIONAL STOP AND RESURFACING FEMUR AXIAL PIN. THE REVISION SURGERY WAS PERFORMED BY DR. (B)(6).

  Patient problems: Joint Laxity

  MAUDE report 18630821 ↗
• InjuryFeb 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  ON 05 JANUARY 2024, B. STEINKAMP (AN ONKOS DISTRIBUTOR) REPORTED THAT A 77-YEAR-OLD MALE PATIENT WHO HAD ALLEGEDLY SUFFERED FROM INSTABILITY IN THE KNEE JOINT INVOLVING A PREVIOUSLY IMPLANTED ELEOS HINGE KNEE REPLACEMENT, UNDERWENT A REVISION SURGERY TO REPLACE THE 10MM TIBIAL POLY SPACER WITH A 20MM TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS WERE ALSO REPLACED AS PART OF THIS REVISION: TIBIAL HINGE W/ ROTATIONAL STOP AND RESURFACING FEMUR AXIAL PIN. THE REVISION SURGERY WAS PERFORMED BY DR. (B)(6).

  Patient problems: Joint Laxity

  MAUDE report 18630733 ↗
• InjuryFeb 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  ON 05 JANUARY 2024, B. STEINKAMP (AN ONKOS DISTRIBUTOR) REPORTED THAT A 77-YEAR-OLD MALE PATIENT WHO HAD ALLEGEDLY SUFFERED FROM INSTABILITY IN THE KNEE JOINT INVOLVING A PREVIOUSLY IMPLANTED ELEOS HINGE KNEE REPLACEMENT, UNDERWENT A REVISION SURGERY TO REPLACE THE 10MM TIBIAL POLY SPACER WITH A 20MM TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS WERE ALSO REPLACED AS PART OF THIS REVISION: TIBIAL HINGE W/ ROTATIONAL STOP AND RESURFACING FEMUR AXIAL PIN. THE REVISION SURGERY WAS PERFORMED BY DR. (B)(6).

  Patient problems: Joint Laxity

  MAUDE report 18630073 ↗
• 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 16966481 ↗
• InjuryMar 24, 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, TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS REMAINED IMPLANTED DURING THE REVISION SURGERY: SEGMENTAL STEM, TIBIAL BASEPLATE, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16616014 ↗
• 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 15996371 ↗
• 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 15982648 ↗
• InjuryNov 23, 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 SURGEON REVISED THE FOLLOWING ELEOS IMPLANTS: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, DISTAL FEMUR, BIOGRIP COLLAR, COLLAR LOCKING RING, CEMENTED STEM EXTENSION, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15855395 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15798589 ↗
• 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 15677479 ↗

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-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-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-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-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