ELEOS Limb Salvage System FS-13120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278FS1312003M0), received between Apr 9, 2020 and Jul 22, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJul 22, 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 AN 82-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT A REVISION ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION. DOCTOR (B)(6) REPORTEDLY REMOVED ALL EXISTING ONKOS HARDWARE FROM THE PATIENT.

  Patient problems: Medical device site infection

  MAUDE report 19799131 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 WHERE THE SURGEON REVISED THE FOLLOWING ELEOS IMPLANTS: RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S INDEX PROCEDURE: PROXIMAL TIBIA, SEGMENTAL STEM, RESURFACING FEMUR, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16255669 ↗
• InjuryFeb 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED MULTIPLE TIMES WITH KNEE EFFUSIONS. THE SURGEON DREW FLUID FROM THE KNEE. THE FLUID WAS ANALYZED AND SHOWED INCREASED LEVELS OF COBALT, TITANIUM, AND CHROMIUM. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE SURGEON DECIDED TO RE-IMPLANT THE ZIMMER BIOMET COMPRESS. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 13581550 ↗
• InjuryFeb 15, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT WAS REVISED ON (B)(6) 2022 FOR AN ALLEGED FEMORAL STEM LOOSENING. DURING THIS REVISION SURGERY THE FOLLOWING WAS EXPLANTED: ELEOS DISTAL FEMUR LEFT SEGMENTAL, ELEOS MALE-FEMALE MIDSECTION 60MM, ELEOS CANAL FILLING STEM 13MMX120MM STRAIGHT SPLINED FULL PLASMA 28MM COLLAR, ELEOS TIBIAL BASEPLATE SIZE 3, ELEOS STEM EXTENSION CANAL FILLING 13MMX140MM STRAIGHT SPLINED SLOTTED, ELEOS TIBIAL POLY SPACER 8MM, ELEOS HINGE W/ ROTATIONAL STOP, AND ELEOS DISTAL FEMUR AXIAL PIN. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE IMPLANTED: ELEOS DISTAL FEMUR LEFT SEGMENTAL, MALE-FEMALE MIDSECTION 40MM, ELEOS POROUS HA TREATED ROUND 34MM 32MM MODULAR POROUS BIOGRIP HA COLLAR, ELEOS CEMENTED STEM 15MMX120MM STRAIGHT FLUTED, ELEOS MODULAR COLLAR LOCKING RING AND IMPACTOR TIP, ELEOS TIBIAL POLY SPACER 8MM, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, AND ELEOS DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13538687 ↗
• InjuryApr 9, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT UNDERWENT A REVISION SURGERY DUE TO A FEMORAL STEM LOOSENING.

  Patient problems: Pain

  MAUDE report 9944481 ↗

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-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