ELEOS™ 25001060ERecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI B27825001060E0), received between Aug 31, 2018 and Nov 18, 2025 — classified as 1 death, 11 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 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 A LONG-TERM PAIN. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Limb Pain

  MAUDE report 23585517 ↗
• 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 23466183 ↗
• InjuryJun 26, 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 62-YEAR-OLD FEMALE PATIENT WITH ELEOS DISTAL FEMUR 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 PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 22342214 ↗
• InjuryJun 26, 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 62-YEAR-OLD FEMALE PATIENT WITH ELEOS DISTAL FEMUR 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 PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 22341640 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 65-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21859223 ↗
• InjuryFeb 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 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 18771383 ↗
• 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 15982663 ↗
• InjuryApr 17, 2021Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A REVISION SURGERY ON(B)(6) 2021 PERFORMED BY DR. MOLLABASHY DUE TO METAL DEBRIS IN THE SOFT TISSUE ENVELOPE. THE SURGEON REMOVED THE IMPLANTS AND WASHED OUT THE AREA TO REMOVE THE METAL DEBRIS. DURING THE OPERATION, IT WAS DETERMINED THAT THE PATIENT ALSO HAD AN INFECTION AROUND THE IMPLANTS. BLOOD WORK DETERMINED THAT THE CHROMIUM LEVELS IN THE PATIENT'S BLOOD WERE HIGH AT APPROXIMATELY 11 [?]G[?]L. NORMAL BLOOD CHROMIUM LEVELS ARE LESS THAN OR EQUAL TO 1.4 [?]G[?]L. ALL OF THE IMPLANTS WERE REMOVED EXCEPT FOR THE FEMORAL STEM WHICH WAS LEFT IN PLACE DUE TO THE SURGEON BELIEVING THAT IT WOULD NEGATIVELY AFFECT THE PATIENT'S FEMUR IF THEY REMOVED IT. THE PATIENT RETURNED FOR A SUBSEQUENT SURGERY TO HAVE ELEOS COMPONENTS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 11683013 ↗
• InjuryApr 6, 2021Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  A (B)(6)-YEAR-OLD FEMALE PATIENT WAS EXPERIENCING PAIN IN HER HIP AFTER MULTIPLE REVISION SURGERIES HAD BEEN PERFORMED OVER THE PAST YEAR. THIS ISSUE STARTED ON (B)(6) 2021. SCAR TISSUE HAD DEVELOPED IN THE SOFT TISSUE CAVITY FROM THE PREVIOUS SURGERIES. THE SURGEON, DR. (B)(6), DECIDED THAT THE PATIENT'S SEGMENTS SHOULD BE SHORTENED TO RELIEVE THE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHERE A 60MM MALE-FEMALE MIDSECTION WAS REMOVED AND REPLACED WITH A 40MM MALE-FEMALE MIDSECTION AND A 50MM MALE-MALE MIDSECTION WAS REMOVED AND REPLACED WITH A 40MM MALE-MALE MIDSECTION. THE PRIMARY ELEOS SURGERY, WHICH WAS PERFORMED FOR UNKNOWN REASONS, WAS PERFORMED ON (B)(6) 2020 TO PLACE A TOTAL FEMUR SYSTEM. THE PATIENT HAD A PROXIMAL FEMUR IMPLANT AND A MALE-FEMALE MIDSECTION REVISED DURING HER PREVIOUS REVISION SURGERY WHICH OCCURRED ON (B)(6) 2020. DURING THE REVISION ON (B)(6) 2021, A 50MM MALE-MALE MIDSECTION WAS REPLACED WITH A 40MM MALE-FEMALE MIDSECTION. A 40MM MALE-FEMALE MIDSECTION AND A PROXIMAL FEMUR WERE REPLACED WITH THE SAME SIZED IMPLANTS. A 60MM MALE-FEMALE MIDSECTION WAS PRESENT DURING THE REVISION BUT WAS NOT REVISED. IT IS BELIEVED THAT THE PATIENT HAS A MICRO

  Patient problems: Scar Tissue

  MAUDE report 11624550 ↗
• InjuryJul 15, 2020Adverse 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 10280081 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT THE SECOND PART OF THEIR REVISION SURGERY WERE A FULL REVISION WAS PERFORMED DUE TO THE PATIENT'S PREVIOUS INFECTION. UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE FEMORAL STEM HAD LOOSENED FROM THE BONE.

  Patient problems: No Information

  MAUDE report 10040325 ↗
• DeathAug 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WENT INTO CARDIAC ARREST, DURING A REVISION SURGERY, AND WAS UNABLE TO BE RESUSCITATED. THE REVISION SURGERY WAS PERFORMED TO REMOVE UNKNOWN COMPONENTS DUE TO A COMMINUTED SUPRACONDYLAR FRACTURE ON THEIR DISTAL FEMUR AND PLACE AN ELEOS DISTAL FEMUR LIMB SALVAGE SYSTEM.

  Patient problems: Sudden Cardiac Death

  MAUDE report 7839699 ↗

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-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-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-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-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
• 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