ELEOS Limb Salvage System FS-21120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278FS2112003M0), received between Feb 24, 2021 and Nov 4, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 FEMORAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23466187 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ONKOS SALES REPRESENTATIVE REPORTED THAT A 74-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF THE FEMORAL STEM.

  Patient problems: Joint Laxity

  MAUDE report 22065830 ↗
• InjuryDec 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN ELEOS SEGMENTAL STEM LOOSENED APPROXIMATELY 8 MONTHS POST OPERATIVELY. THE PATIENT UNDERWENT THEIR INDEX PROCEDURE ON 02 MARCH 2022, WHERE THE PATIENT WAS IMPLANTED WITH THE FOLLOWING DEVICES: ELEOS CANAL FILLING STEM, DISTAL FEMUR AXIAL PIN, TIBIAL HINGE, POLY SPACER, STEM EXTENSION, DISTAL FEMUR, TIBIAL BASEPLATE, AND A TIBIAL BASEPLATE TAPERED SCREW. DURING THE PATIENT'S REVISION PROCEDURE ON 23 NOVEMBER 2022, THE LOOSENED 21MM X 120MM CANAL FILLING STEM WAS REMOVED AND REPLACED WITH A 15MM X 152MM CEMENTED STEM. THE FOLLOWING DEVICES WERE ALSO REPLACED: POLY SPACER, DISTAL FEMUR, DISTAL FEMUR AXIAL PIN, AND A TIBIAL HINGE. NO ISSUES WERE REPORTED FOR THESE REPLACED DEVICES. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992052 ↗
• InjurySep 27, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO LOOSENING OF THE PRESSFIT SEGMENTAL STEM. SEVERAL MONTHS AFTER THE PATIENT'S ORIGINAL ELEOS SURGERY, THE PATIENT PRESENTED WITH A LOOSE STEM THAT WAS CONFIRMED RADIOGRAPHICALLY. DURING THE REVISION SURGERY, THE SURGEON REVISED THE SEGMENTAL STEM, DISTAL FEMUR, MALE-FEMALE MIDSECTION, DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. NO FURTHER INFORMATION REGARDING THIS EVENT WAS MADE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12537674 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS EXPERIENCING PAIN AND SURGICAL INTERVENTION WAS REQUIRED TO REVISE IMPLANTS.

  Patient problems: Pain

  MAUDE report 11375655 ↗

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-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-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-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
• 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