ELEOS™ KSP16140ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B278KSP16140E0), received between Apr 29, 2020 and Jun 10, 2026 — classified as 7 injuries.

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.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 55-YEAR-OLD MALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION ON (B)(6) 2026 DUE TO LOOSENING OF THE FEMORAL STEM. PATIENT WAS EXPERIENCING PAIN AT THE KNEE, SURGEON REPLACED STEM COMPONENT. THIS REPORT CAPTURES ELEOS STEM EXTENSION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening

  MAUDE report 25457354 ↗
• InjuryDec 9, 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. RESURFACING FEMUR DISASSOCIATED FROM THE STEM, NO SET SCREW WAS USED WHEN ORIGINALLY IMPLANTED. REPLACED STEM AND FEMUR COMPONENT. THIS REPORT CAPTURES ELEOS STEM EXTENSION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23759852 ↗
• InjuryNov 18, 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 DISSASOCIATION OF STEM EXTENSION FROM FEMUR. THIS REPORT CAPTURES ELEOS STEM EXTENSION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 23588860 ↗
• 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 16255672 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 DUE TO AN ALLEGED INFECTION. THE PATIENT'S INDEX SURGERY OCCURED ON (B)(6) 2021 WHERE THE PATIENT WAS IMPLANTED WITH THE FOLLOWING IMPLANTS: ELEOS PROXIMAL TIBIA, ELEOS RESURFACING FEMUR AXIAL PIN, ELEOS POLY SPACER, ELEOS TIBIAL HINGE, ELEOS SEGMENTAL STEM, ELEOS STEM EXTENSION, AND ELEOS RESURFACING FEMUR. DURING THE REVISION PROCEDURE, THE ELEOS PROXIMAL TIBIA, ELEOS RESURFACING FEMUR AXIAL PIN, ELEOS POLY SPACER, AND ELEOS TIBIAL HINGE WERE REMOVED AND REPLACED. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY, AS THE PATIENT UNDERWENT A REVISION PROCEDURE. ALL THE DEVICES IMPLANTED AT THE TIME OF INFECTION WILL BE REPORTED. THIS REPORT CAPTURES THE ELEOS STEM EXTENSION.

  Patient problems: Unspecified Infection

  MAUDE report 15825828 ↗
• InjuryNov 17, 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 AN ALLEGED INFECTION. THE SURGEON PERFORMED INCISION AND DRAINAGE AND REVISED THE FOLLOWING ELEOS IMPLANTS: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED: DISTAL FEMUR, (2) TIBIAL BLOCK AUGMENTS, TIBIAL BASEPLATE, CANAL-FILLING SEGMENTAL STEM, CANAL-FILLING STEM EXTENSION, AND MALE-FEMALE MIDSECTION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12830445 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT THEIR FEMUR, TIBIA, AND FIBULA FRACTURED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10009588 ↗

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-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-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-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