ELEOS™ KSP13140ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI B278KSP13140E0), received between Aug 6, 2020 and Mar 3, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 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.

• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER, ELEOS DISTAL FEMUR AXIAL PIN AND ELEOS DISTAL FEMUR. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CANAL-FILLING STEM EXTENSION, TIBIAL BASEPLATE, MALE-FEMALE MIDSECTIONS, MALE-MALE MIDSECTION, AND PROXIMAL FEMUR. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16482889 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2023 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER AND ELEOS DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 16297186 ↗
• InjuryMay 19, 2022Adverse 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 FOLLOWING ELEOS IMPLANTS WERE REVISED: ELEOS TIBIAL POLY SPACER 8MM, ELEOS RESURFACING FEMUR AXIAL PIN SIZE: 4, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS STEM EXTENSION CANAL FILLING SIZE: 14MM X 140MM STRAIGHT SPLINED SLOTTED, ELEOS TIBIAL BLOCK AUGMENT SIZE: 2 THICKNESS: 5MM, ELEOS TIBIAL BASEPLATE SIZE: 2, ELEOS STEM EXTENSION CEMENTED SIZE: 12MM X 100MM STRAIGHT FLUTED, ELEOS TIBIAL BLOCK AUGMENT SIZE: 2 THICKNESS: 5MM, AND ELEOS RESURFACING FEMUR SIZE 4 LEFT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 14438882 ↗
• InjuryDec 7, 2021Loosening 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) 2021 DUE TO LOOSENING OF THEIR 14X140MM CANAL-FILLING STEM EXTENSION. DURING THE REVISION SURGERY, THE SURGEON PLACED A 15X140MM CANAL-FILLING STEM EXTENSION. THE SURGEON ALSO REVISED THE FOLLOWING ELEOS IMPLANTS: RESURFACING FEMUR, TIBIAL POLY SPACER, RESURFACING FEMUR AXIAL PIN, MALE-FEMALE MIDSECTION, AND TIBIAL HINGE COMPONENT. FURTHER INFORMATION REGARDING THIS ADVERSE EVENT HAS NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12954937 ↗
• InjurySep 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6). THE SURGERY WAS PERFORMED DUE TO ULCERATION AROUND ELEOS TOTAL FEMUR COMPONENT. DURING THE SURGERY, THE SURGEON REMOVED ALL IMPLANTS THAT WERE IMPLANTED AT THE TIME AS IT WAS DECIDED THAT THE PATIENT'S LEG WOULD BE AMPUTATED ABOVE THE KNEE. TO GIVE THE PATIENT'S THIGH STRUCTURE, A MALE-FEMALE MIDSECTION WITH A CUSTOM END CAP IMPLANT WAS PLACED IN THE PATIENT'S UPPER LEG.

  Patient problems: Ulcer

  MAUDE report 12441355 ↗
• InjuryAug 6, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 DUE TO A PERIPROSTHETIC FRACTURE OF THE ANTERIOR TIBIA AS WELL AS DISSOCIATION BETWEEN THE TIBIAL BASEPLATE AND THE TIBIAL STEM EXTENSION. THE TIBIAL BASEPLATE, STEM EXTENSION, POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN WERE EXPLANTED AND REPLACED WITH NEW IMPLANTS. THE PERIPROSTHETIC FRACTURE WAS ALSO REPAIRED DURING THE REVISION.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 10373226 ↗

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-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-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-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-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