ELEOS™ KTAGB410ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI B278KTAGB410E0), received between Nov 17, 2021 and Oct 23, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 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 FOR A POLY SWAP OF ELEOS IMPLANTS. IT IS LIKELY THAT THE PATIENT'S IMPLANTED ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE COMPONENENT, AND ELEOS POLYSPACER WERE REMOVED AND REPLACED. ON 23 SEPTEMBER 2022, ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS EVENT: IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION AND UNDERWENT A REVISION SURGERY ON 27 JUNE 2022. DURING THE REVISION SURGERY, THE SURGEON REVISED THE TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S SURGERY ON (B)(6) 2022: DISTAL FEMUR, MALE-FEMALE MIDSECTION, CEMENTED SEGMENTAL STEM, CANAL-FILLING SEGMENTAL STEM, TIBIAL BASEPLATE, TWO TIBIAL BLOCK AUGMENTS, AND A CEMENTED STEM EXTENSION. ALL PARTS IMPLANTED AT THE TIME OF INFECTION WILL BE REPORTED. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION. THIS RECORD CAPTURES THE SECOND ELEOS TIBIAL BLOCK AUGMENT.

  Patient problems: Unspecified Infection

  MAUDE report 15656626 ↗
• InjuryOct 23, 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 FOR A POLY SWAP OF ELEOS IMPLANTS. IT IS LIKELY THAT THE PATIENT'S IMPLANTED ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE COMPONENTS, AND ELEOS POLYSPACER WERE REMOVED AND REPLACED. ON 23 SEPTEMBER 2022, ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS EVENT: IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION SURGERY, THE SURGEON REVISED THE TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S SURGERY ON (B)(6) 2022: DISTAL FEMUR, MALE-FEMALE MIDSECTION, CEMENTED SEGMENTAL STEM, CANAL-FILLING SEGMENTAL STEM, TIBIAL BASEPLATE, TWO TIBIAL BLOCK AUGMENTS, AND A CEMENTED STEM EXTENSION. ALL PARTS IMPLANTED AT THE TIME OF INFECTION WILL BE REPORTED. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION. THIS RECORD CAPTURES THE ELEOS TIBIAL BLOCK AUGMENT.

  Patient problems: Unspecified Infection

  MAUDE report 15656625 ↗
• 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 12830416 ↗
• 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 12830412 ↗

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-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-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-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-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-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