ELEOS Limb Salvage System FS-12120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI B278FS1212003M0), received between Aug 16, 2021 and May 15, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryMay 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ONKOS SALES REPRESENTATIVE REPORTED THAT A 63-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY DUE TO A PERI-PROSTHETIC FRACTURE OF THE DISTAL FEMUR. THE BONE FRACTURE REPORTEDLY OCCURRED AFTER THE PATIENT FELL.

  Patient problems: Fall; Limb Fracture

  MAUDE report 22030975 ↗
• InjuryMar 27, 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 58-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR AND PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21713526 ↗
• InjurySep 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 DUE TO A SUSPECTED LOOSENING OF THEIR 12X120MM STRAIGHT CANAL-FILLING SEGMENTAL STEM. THE PATIENT HAD PREVIOUSLY ENDURED A FALL. DURING THE REVISION SURGERY, THE PATIENT'S 12X120MM STRAIGHT CANAL-FILLING SEGMENTAL STEM WAS REVISED TO A 15X120MM STRAIGHT MODULAR COLLAR CEMENTED SEGMENTAL STEM. THE FOLLOWING ELEOS IMPLANTS WERE ALSO REVISED: MALE FEMALE MIDSECTION AND TIBIAL POLY SPACER. THERE WERE NO REPORTED MALFUNCTIONS OF THE MALE FEMALE MIDSECTION AND TIBIAL POLY SPACER. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAVE BEEN REPORTED.

  Patient problems: Fall

  MAUDE report 17803456 ↗
• InjuryAug 17, 2023Adverse 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 DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, RESURFACING FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: STEM EXTENSION, SEGMENTAL STEM, RESURFACING FEMUR, AND PROXIMAL TIBIA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 17566114 ↗
• MalfunctionSep 14, 2021Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO SUBSIDENCE OF THE CANAL-FILLING SEGMENTAL STEM IN THE PATIENT'S TIBIA. THE PATIENT UNDERWENT THEIR ORIGINAL ELEOS SURGERY ON (B)(6) 2021 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: CUSTOM PROXIMAL TIBIA, TIBIAL POLY SPACER, TIBIAL HINGE W. ROTATIONAL STOP, DISTAL FEMUR AXIAL PIN, AND CANAL-FILLING SEGMENTAL STEM. POST OPERATION FILMS SHOWED A SUBSIDENCE OF THE CANAL-FILLING SEGMENTAL STEM AFTER SEVERAL WEEKS. DR. (B)(6) REVISED THE CANAL-FILLING SEGMENTAL STEM TO AN ELEOS MODULAR CEMENTED STEM WITH A BIOGRIP COLLAR. THE SURGEON ALSO REVISED THE TIBIAL POLY SPACER, TIBIAL HINGE, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12467499 ↗
• InjuryAug 16, 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 A PERIPROSTHETIC FRACTURE BELOW THE PATIENT'S SEGMENTAL STEM. THE PATIENT UNDERWENT THEIR ORIGINAL SURGERY ON (B)(6) 2020 WHERE THE FOLLOWING IMPLANTS WERE PLACED: ELEOS CANAL-FILLING SEGMENTAL STEM (12X120MM), ELEOS PROXIMAL FEMUR (95MM), ELEOS MALE-FEMALE MIDSECTION (60MM), ELEOS FEMORAL HEAD (32MM, +0MM TAPER), AND MICROPORT GUARDIAN BIPOLAR SHELL (46MM). DURING THE REVISION SURGERY, THE ELEOS SEGMENTAL STEM WAS EXPLANTED AND AN ELEOS DISTAL FEMORAL SYSTEM WAS PLACED. NO ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 12324960 ↗

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-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-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-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