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ELEOS™ 25000013ERecalls & reported problems

Onkos Surgical, Inc. · ELEOS™ SEGMENTAL STEM, CEMENTED STRAIGHT, FLUTED, 25MM COLLAR 13MM X 152MM · Class 2 · Implant

All models of ELEOS (127)

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

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B27825000013E0), received between Mar 20, 2019 and Feb 12, 2022 — classified as 5 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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem5
  • Insufficient Device Problem Information1

Patient problems

  • Unspecified Infection4
  • Insufficient Information2
  • Cardiac Arrest1
  • Wound Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • 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 13519269 ↗
  • InjuryFeb 8, 2022Adverse 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) 2022 DUE TO AN ALLEGED INFECTION. THE SURGEON PERFORMED A POLY SWAP. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY ON (B)(6) 2021: DISTAL FEMUR, CEMENTED SEGMENTAL STEM, MALE-FEMALE MIDSECTION, CEMENTED STEM EXTENSION, AND TIBIAL BASEPLATE. ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS NOT BEEN PROVIDED.

    Patient problems: Unspecified Infection

    MAUDE report 13487412 ↗
  • InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE SURGEON PERFORMED A POLY SWAP. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY ON (B)(6) 2021: DISTAL FEMUR, CEMENTED SEGMENTAL STEM, MALE-FEMALE MIDSECTION, CEMENTED STEM EXTENSION, AND TIBIAL BASEPLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Insufficient Information; Unspecified Infection

    MAUDE report 13261616 ↗
  • 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 IMPLANT REMAINS IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CEMENTED SEGMENTAL STEM. THE SURGEON USED ANTIBIOTIC CEMENT. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

    Patient problems: Unspecified Infection; Wound Infection

    MAUDE report 12972247 ↗
  • InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WENT INTO CARDIAC ARREST SHORTLY AFTER THE STEM WAS CEMENTED INTO PLACE.

    Patient problems: Cardiac Arrest

    MAUDE report 8438281 ↗

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-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-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-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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