ELEOS Limb Salvage System FB-11152-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI B278FB1115203M0), received between Nov 4, 2021 and Apr 3, 2024 — classified as 6 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2024Unstable; Unstable

  IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A 54-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024 DUE TO ASEPTIC LOOSENING OF THE FEMORAL CANAL FILLING STEM.

  Patient problems: Insufficient Information

  MAUDE report 19037853 ↗
• 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 74-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF AN ELEOS 11X152MM PRESS FIT SEGMENTAL STEM. THE EXPLANTED SEGMENTAL STEM WAS REPORTEDLY FIXATED WITH BONE CEMENT IN THE FEMUR AND HAD BECOME LOOSE, CAUSING THE PATIENT TO EXPERIENCE PAIN IN THE IN THE THIGH. THE SURGEON DETERMINED THAT THIS REVISION WAS NECESSARY AND OPTED TO BUILD A NEW CONSTRUCT TO ENSURE OPTIMAL FIXATION.

  Patient problems: Implant Pain

  MAUDE report 18772029 ↗
• InjuryJun 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S 11X152MM BOWED SEGMENTAL STEM FRACTURED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 AND THE FOLLOWING IMPLANTS WERE REVISED: ONE MALE-FEMALE MIDSECTION AND ONE SEGMENTAL STEM. THE PATIENT'S 11X152MM CANAL-FILLING BOWED SEGMENTAL STEM WAS REVISED TO A 12X120MM CANAL-FILLING STRAIGHT SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17218538 ↗
• InjuryMar 29, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THEIR THIGH. THROUGH AN X-RAY, IT WAS SUSPECTED THAT THERE WAS LOOSENING OF THE PATIENT'S CANAL-FILLING SEGMENTAL STEM. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 WHERE THE 11X152MM CANAL-FILLING BOWED SEGMENTAL STEM WAS REVISED TO A 14X152MM CANAL-FILLING BOWED SEGMENTAL STEM. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE ALSO REVISED: DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, MALE-FEMALE MIDSECTION, AND TIBIAL POLY SPACER. THERE WERE NO ALLEGED MALFUNCTIONS WITH THE DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, MALE-FEMALE MIDSECTION, AND TIBIAL POLY SPACER. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 16637779 ↗
• InjuryFeb 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A BROKEN STEM (B)(6) 2022 AFTER RECEIVING DISTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2019. THE IMPLANTING SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS DISTAL FEMUR RIGHT SEGMENTAL, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP, AND ELEOS TIBIAL POLY SPACER 8MM. ALSO, DURING THE REVISION SURGERY, THE ELEOS CANAL FILLING STEM 11MM 152MM BOWED SLOTTED SPLINE 2/3 PLASMA 28MM COLLAR WAS REPLACED WITH THE ELEOS CEMENTED STEM 13MMX120MM STRAIGHT FLUTED, ELEOS MODULAR POROUS BIOGRIP HA COLLAR POROUS HA TREATED ROUND 34MM 28MM, AND ELEOS MODULAR COLLAR LOCKING RING AND IMPACTOR TIP. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13501775 ↗
• InjuryNov 4, 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. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: MALE-FEMALE MIDSECTION (40MM). DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY: CANAL-FILLING SEGMENTAL STEM (11X152MM), TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION (12X100MM). NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12751639 ↗

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-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-1857-2025 · Sep 22, 2024 · Open, Classified
  ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
• 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-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-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
• 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