ELEOS Limb Salvage System FS-17120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B278FS1712003M0), received between May 11, 2023 and Oct 24, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4) AN ONKOS SALES REPRESENTATIVE, THAT A MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE INFECTION. THE ELEOS CANAL FILLING SEGMENTAL STEM REPORTEDLY LOOSENED DURING THE REMOVAL OF THE ATTACHED MIDSECTION.

  Patient problems: Medical device site infection

  MAUDE report 20521978 ↗
• InjurySep 8, 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 17X120MM STRAIGHT CANAL-FILLING SEGMENTAL STEM. DURING THE REVISION SURGERY, THE PATIENT'S 17X120MM STRAIGHT CANAL-FILLING SEGMENTAL STEM WAS REVISED TO A 20X120MM STRAIGHT CANAL-FILLING SEGMENTAL STEM. THE FOLLOWING ELEOS IMPLANTS WERE ALSO REVISED: DISTAL FEMUR, DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL BASEPLATE, CEMENTED STEM EXTENSION, TIBIAL BLOCK AUGMENTS, AND TIBIAL POLY SPACER. THERE WERE NO REPORTED MALFUNCTIONS OF THE DISTAL FEMUR, DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL BASEPLATE, CEMENTED STEM EXTENSION, TIBIAL BLOCK AUGMENTS, AND TIBIAL POLY SPACER. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 17712118 ↗
• InjuryMay 11, 2023Loosening 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) 2023 DUE TO PATELLA DISLOCATION. DURING THE REVISION SURGERY IT WAS IDENTIFIED THAT THE FEMORAL SEGMENTAL STEM HAD LOOSENED AND SUBSIDED. THE SURGEON REVISED THE 17X120MM CANAL-FILLING SEGMENTAL STEM TO A 15X120MM CEMENTED MODULAR COLLAR SEGMENTAL STEM. DURING THE REVISION SURGERY, THE SURGEON ADDITIONALLY REVISED THE FOLLOWING ELEOS DEVICES: DISTAL FEMUR, TIBIAL HINGE COMPONENT, POLY SPACER, MALE-FEMALE MIDSECTION, AND DISTAL FEMUR AXIAL PIN. THERE WERE NO ALLEGED MALFUNCTIONS OF THE DISTAL FEMUR, TIBIAL HINGE COMPONENT, POLY SPACER, MALE-FEMALE MIDSECTION, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 16911092 ↗

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-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-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-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-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-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