ELEOS Limb Salvage System FS-14120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B278FS1412003M0), received between Nov 7, 2021 and Mar 9, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO A FRACTURE. THIS REPORT CAPTURES ELEOS FEMORAL STEM.

  Patient problems: Periprosthetic fracture

  MAUDE report 24549173 ↗
• MalfunctionNov 11, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT'S CANAL-FILLING SEGMENTAL STEM LOOSENED IN THEIR RIGHT DISTAL FEMUR AND IT WILL REQUIRE SURGICAL INTERVENTION. A REVISION SURGERY IS ANTICIPATED BUT HAS NOT YET BEEN SCHEDULED. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15784192 ↗
• InjurySep 28, 2022Loosening 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) 2022 DUE TO THEIR CANAL-FILLING SEGMENTAL STEM LOOSENING. DURING THE REVISION SURGERY, THE CANAL-FILLING SEGMENTAL STEM WAS EXPLANTED AND A BIOGRIP POROUS MODULAR COLLAR STEM WAS PLACED. ADDITIONALLY, THE MALE-FEMALE MIDSECTION WAS REVISED. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15496138 ↗
• InjurySep 16, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN DUE TO A LOOSENED ELEOS SEGMENTAL STEM- THE EVENT WAS CONFIRMED THROUGH RADIOGRAPHICAL IMAGING BY THE SURGEON. THE UNDERWENT REVISION SURGERY DUE TO THE LOOSENED STEM, APPROXIMATELY TWO YEARS POST-OPERATIVELY. THE PATIENT WAS INITIALLY IMPLANTED WITH THE ELEOS DISTAL FEMUR REPLACEMENT SYSTEM ON (B)(6) 2020, AND REVISED ON (B)(6) 2022. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION SURGERY. THE FOLLOWING DEVICES WERE ALSO REMOVED AND REPLACED: ELEOS DISTAL FEMUR, ELEOS TIBIAL HINGE, ELEOS AXIAL PIN, AND AN ELEOS POLY SPACER. NO ALLEGED ISSUES WERE REPORTED AGAINST THESE DEVICES; THEREFORE, THEY WILL BE CONSIDERED CONCOMITANT.

  Patient problems: Pain

  MAUDE report 15441856 ↗
• InjuryApr 6, 2022Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON(B)(6)2022. THE PATIENT HAD PATELLA TRACKING ISSUES DUE TO LOOSENING OF AN ELEOS CANAL FILLING STEM POST-OPERATIVELY. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO REVISION PROCEDURE. DURING THE REVISION PROCEDURE, THE CANAL FILLING STEM, DISTAL FEMUR AXIAL PIN, TIBIAL HINGE, AND TIBIAL POLYSPACER WERE REPLACED. NO DEVICE SPECIFIC ISSUES WERE REPORTED FOR THE DISTAL FEMUR AXIAL PIN, TIBIAL HINGE, AND TIBIAL POLYSPACER; THEREFORE, THESE DEVICES ARE CONCOMITANT. THIS RECORD CAPTURES THE ELEOS CANAL FILLING STEM.

  Patient problems: Subluxation

  MAUDE report 14023465 ↗
• InjuryNov 22, 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 THEIR CANAL-FILLING SEGMENTAL STEM LOOSENING. DURING THE REVISION SURGERY, THE CANAL-FILLING SEGMENTAL STEM WAS EXPLANTED AND A BIOGRIP POROUS MODULAR COLLAR STEM WAS PLACED. ADDITIONALLY, THE DISTAL FEMUR AXIAL PIN AND MALE-FEMALE MIDSECTION WERE REVISED. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12857937 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED THEIR FEMUR AND THAT THEIR IMPLANTED SEGMENTAL STEM NEEDED TO BE REVISED. A REVISION SURGERY WAS SCHEDULED FOR THE PATIENT BUT WAS CANCELLED AND HAS NOT BEEN RESCHEDULED YET. NO FURTHER INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12761696 ↗

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-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-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-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