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ELEOS™ 25000011ERecalls & reported problems

Onkos Surgical, Inc. · ELEOS™ SEGMENTAL STEM, CEMENTED STRAIGHT, FLUTED, 25MM COLLAR 11MM X 152MM · Class 2 · Implant

All models of ELEOS (127)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI B27825000011E0), received between Apr 22, 2020 and Oct 21, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem4
  • Fracture2
  • Loose or Intermittent Connection1
  • Loss of Osseointegration1

Patient problems

  • Unspecified Infection4
  • Insufficient Information2
  • Pain2

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 21, 2022Fracture; Fracture

    IT WAS REPORTED THAT THE PATIENT'S FEMORAL 11X152MM BOWED SEGMENTAL STEM FRACTURED. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2022 AND THE FOLLOWING IMPLANTS WERE REVISED: TWO MALE-FEMALE MIDSECTIONS, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATIOIN REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 15655116 ↗
  • InjuryJun 14, 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: TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, DISTAL FEMUR, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CEMENTED SEGMENTAL STEM, CANAL-FILLING STEM EXTENSION, AND TIBIAL BASEPLATE. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 14690849 ↗
  • InjuryDec 28, 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. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, PROXIMAL TIBIA, CEMENTED BOWED STEM, CEMENTED STRAIGHT STEM, POLY SPACER, DISTAL FEMUR AXIAL PIN, AND TIBIAL HINGE COMPONENT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

    Patient problems: Unspecified Infection

    MAUDE report 13096024 ↗
  • 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 12164247 ↗
  • 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 11382115 ↗
  • InjuryFeb 16, 2021Loose or Intermittent Connection

    A (B)(6) FEMALE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6) DUE TO A FEMORAL STEM LOOSENING. THE SURGEON REPLACED THE CEMENTED SEGMENTAL STEM, TWO MALE-FEMALE MIDSECTIONS, A DISTAL FEMUR IMPLANT, A DISTAL FEMUR AXIAL PIN, AND A TIBIAL HINGE COMPONENT DURING THE REVISION. THE SEGMENTAL STEM THAT LOOSENED WAS CEMENTED WITH PALANCOS BONE CEMENT DURING THE PRIMARY ELEOS SURGERY. IT IS UNKNOWN WHAT THE PATIENT'S BONE QUALITY IS. IT IS ALSO UNKNOWN IF THE PATIENT SUSTAINED A TRAUMA PRIOR TO THE FAILURE. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THE PATIENT'S WEIGHT IS UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 11335585 ↗
  • InjuryJun 17, 2020Fracture; Fracture

    PATIENT SUFFERED FORM A FALL AND UPON REVIEW OF RADIOGRAPHS, IT WAS IDENTIFIED THAT THEIR FEMORAL STEM HAD FRACTURED REQUIRING SURGICAL INTERVENTION.

    Patient problems: Pain

    MAUDE report 10163593 ↗
  • InjuryApr 22, 2020Loss of Osseointegration; Loss of Osseointegration

    PATIENT UNDERWENT A REVISION SURGERY DUE TO THE FEMORAL STEM LOOSENING.

    Patient problems: Pain

    MAUDE report 9987666 ↗

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-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-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-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
  • 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

Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

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