ELEOS™ 25001050ERecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI B27825001050E0), received between Jun 3, 2021 and Feb 3, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY P. MEDINA, AN ONKOS SALES REPRESENTATIVE, THAT A 21-YEAR-OLD MALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO LOOSENING OF CEMENTED STEM. IT WAS REPORTED THAT THE STEM WAS REPLACED FOR BETTER FIXATION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening

  MAUDE report 24247243 ↗
• InjuryNov 4, 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 WASHED OUT AND SWAPPED ALL MODULAR COMPONENTS 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 23466202 ↗
• InjuryAug 20, 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 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 20004031 ↗
• InjuryJul 3, 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 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, (B)(6), WASHED OUT THE OPERATIVE JOINT AND REPLACED THE ELEOS DEVICES.

  Patient problems: Medical device site infection

  MAUDE report 19671990 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT WAS REPORTEDLY REVISED DUE TO A LEG LENGTH DISCREPANCY, REQUIRING THE OPERATIVE LEG TO BE SHORTENED. P. MEDINA, AN ONKOS SALES REPRESENTATIVE, REPORTED THAT A 50MM MALE-FEMALE MIDSECTION WAS REMOVED AND AN 8MM POLY SPACER WAS REPLACED BY A 16MM POLY SPACER DURING THE REVISION SURGERY. ALL OTHER EXPLANTED IMPLANTS WERE SWAPPED AS PART OF THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19038061 ↗
• 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 FIRST 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 TWO (2) ELEOS COMPONENTS EXPLANTED AND REPLACED.

  Patient problems: Medical device site infection

  MAUDE report 18989301 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY T. STAMPER, AN ONKOS SALES REPRESENTATIVE, THAT A 62-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE SURGEON SUSPECTED AN INFECTION BECAUSE THE SURGICAL WOUND NEVER FULLY HEALED. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2023. THE PATIENT WAS REPORTEDLY AN ONCOLOGY PATIENT. ALL ELEOS EXPLANTED IMPLANTS WERE REPLACED WITH NEW IMPLANTS DURING THE WASHOUT REVISION SURGERY. THESE DEVICES WERE NOT RETURNED FOR EVALUATION. ALL OTHER ELEOS DEVICES IMPLANTED DURING THE PRIMARY SURGERY REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: Medical device site infection

  MAUDE report 18818119 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY ALAN GURLER, AN ONKOS DISTRIBUTOR, THAT A 16-YEAR-OLD MALE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION OF AN IMPLANTED ELEOS DISTAL FEMUR REPLACEMENT ON (B)(6) 2024.

  Patient problems: Medical device site infection; Pain

  MAUDE report 18771382 ↗
• InjurySep 7, 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. A REVISION SURGERY HAS NOT YET BEEN SCHEDULED. THE PATIENT HAS THE FOLLOWING ELEOS DEVICES IMPLANTED: TIBIAL POLY SPACER, DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, STEM EXTENSION, THREE MALE-FEMALE MIDSECTIONS, PROXIMAL FEMUR, AND MALE-MALE MIDSECTION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17704040 ↗
• InjuryOct 6, 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 REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP AND ELEOS TIBIAL POLY SPACER.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15555444 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2022 FOR AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE EXPLANTED: ELEOS PROXIMAL TIBIA 87MM, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS TIBIAL POLY SPACER 8MM, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE IMPLANTED: ELEOS PROXIMAL TIBIA 87MM, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS TIBIAL POLY SPACER 8MM, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS RESURFACING FEMUR AXIAL PIN SIZE 2. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13586294 ↗
• InjuryFeb 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2022 FOR AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE EXPLANTED: ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS TIBIAL POLY SPACER 8MM, ELEOS SEGMENTAL STEM CEMENTED 13MM X 152MM STRAIGHT FLUTED 25MM COLLAR, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS DISTAL FEMUR RIGHT SEGMENTAL, AND ELEOS DISTAL FEMUR AXIAL PIN. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE IMPLANTED: ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS TIBIAL POLY SPACER 8MM, A MICROPORT STEM AND A CEMENT SPACER. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS TIBIAL BASEPLATE SIZE 2 AND ELEOS STEM EXTENSION CANAL FILLING 12MM X 100MM STRAIGHT SPLINED SLOTTED. IT WAS REPORTED THAT THE SURGEON PLANS TO HAVE ANOTHER REVISION SURGERY. NO REVISION SURGERY HAS BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13519266 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT HAD AN ALLEGED FALL THAT CONTRIBUTED TO AN ALLEGED INFECTION THEY PRESENTED WITH AFTER RECEIVING TOTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2021. THE IMPLANTING SURGEON PERFORMED A DISTAL FEMUR REVISION SURGERY ON (B)(6) 2022 AND THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT W/O ROTATIONAL STOP, ELEOS TIBIAL BASEPLATE SIZE 3, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL POLY SPACER 8MM AND ELEOS DISTAL FEMUR. THE FOLLOWING IMPLANTS REMAIN IMPLANTED IN THE PATIENT: ELEOS STEM EXTENSION CEMENTED 12MM X100MM STRAIGHT FLUTED, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS MALE-FEMALE MIDSECTION 40MM, ELEOS MALE-FEMALE MIDSECTION 40MM, ELEOS PROXIMAL FEMUR 98MM LEFT 135 DEG, AND ELEOS MALE-MALE MIDSECTION 40MM. IT WAS REPORTED THAT THE SURGEON PLANS TO HAVE ONE MORE REVISION SURGERY WHEN THE INFECTION CLEARS UP. NO REVISION SURGERY HAS BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Fall; Insufficient Information; Unspecified Infection

  MAUDE report 13500637 ↗
• 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 13011501 ↗
• InjuryDec 9, 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 GOT INTO A CAR ACCIDENT WHICH OPENED THEIR INCISION AND IT BECAME INFECTED. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, MALE-FEMALE MIDSECTION, POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S PREVIOUS SURGERIES: CEMENTED SEGMENTAL STEM, CANAL-FILLING STEM EXTENSION, AND TIBIAL BASEPLATE. THE SURGEON USED ANTIBIOTIC CEMENT. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection; Wound Infection

  MAUDE report 12972179 ↗
• 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 12840241 ↗
• InjuryJun 3, 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: DISTAL 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: DISTAL FEMUR, FEMORAL HEAD, STEM EXTENSION, 140MM MALE-FEMALE MIDSECTION, 50MM MALE-FEMALE MIDSECTION, RESURFACING PATELLA, 50MM MALE-MALE MIDSECITON, TIBIAL BASEPLATE. AND A PROXIMAL FEMUR. THE SURGEON REMOVED IMPLANTS WITH POLY COMOPENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11935733 ↗

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-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-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-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