ELEOS Limb Salvage System FB-17152-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI B278FB1715203M0), received between Aug 14, 2020 and Nov 5, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 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 34-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF THE ELEOS CANAL FILLING SEGMENTAL STEM THAT WAS INSERTED INTO THE FEMUR. THE REVISION WAS PERFORMED BY DOCTOR (B)(6) ON (B)(6) 2024.

  Patient problems: Joint Laxity

  MAUDE report 20612370 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY S. STEINERT, AN ONKOS SALES REPRESENTATIVE, THAT A 67-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY DUE TO FRACTURE OF THE ELOS CANAL FILLING SEGMENTAL STEM THAT WAS INSERTED INTO THE PATIENT'S FEMUR.

  Patient problems: Failure of Implant

  MAUDE report 20464787 ↗
• InjuryJun 30, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. RADIOGRAPHICALLY, IT WAS FOUND THAT THE PATIENT'S 17X152MM CANAL-FILLING BOWED SEGMENTAL STEM HAD LOOSENED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 WHERE THE SURGEON REVISED THE PATIENT'S 17X152MM CANAL-FILLING BOWED SEGMENTAL STEM TO A 19X152MM CANAL-FILLING BOWED SEGMENTAL STEM. THE SURGEON ALSO REVISED THE DISTAL FEMUR, 2 MALE-FEMALE MIDSECTIONS, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 14880608 ↗
• InjuryAug 14, 2020Fracture; Fracture

  THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 DUE TO A FRACTURED FEMORAL GUARDIAN SEGMENTAL STEM WHICH OCCURED WHEN THE PATIENT FELL. THIS CAUSED THE STEM TO MIGRATE OUT OF POSITION. THE SURGEON REPLACED THE STEM EXTENSION WITH AN ELEOS STEM EXTENSION. THE SURGEON FOUND A DEFORMITY TO THE FEMUR THAT MADE IT DIFFICULT TO PLACE THE IMPLANT. POST-OPERATIVE X-RAYS WERE TAKEN AND THE SURGEON DECIDED TO BRING THE PATIENT BACK TO REMOVE THE DAMAGED BONE. ON (B)(6) 2020, THE SURGEON RESECTED THE DAMAGED PART OF THE FEMUR AND ADDED A MIDSECTION IMPLANT TO REPLACE THE LENGTH. HE ALSO REPLACED THE ELEOS STEM EXTENSION WITH A NEW ELEOS STEM EXTENSION. HOWEVER, THERE WAS NO FAILURE OF THE ELEOS STEM EXTENSION.

  Patient problems: Pain

  MAUDE report 10409715 ↗

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-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-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-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