ELEOS™ KSP14100ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B278KSP14100E0), received between Mar 10, 2020 and Aug 17, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, RESURFACING FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: STEM EXTENSION, SEGMENTAL STEM, RESURFACING FEMUR, AND PROXIMAL TIBIA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 17566113 ↗
• InjuryMar 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON 01 (B)(6) 2023, DUE TO LOOSENING OF THE PATIENT'S ELEOS RESURFACING FEMUR AND ELEOS STEM EXTENSION. THE PATIENT WAS REVISED TO REMOVE AND REPLACE THOSE TWO COMPONENTS. THE PATIENT'S REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE PATIENT'S REVISION PROCEDURE. THIS RECORD CAPTURES THE ELEOS STEM EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482049 ↗
• InjuryFeb 15, 2023Fracture; Unintended Movement; Fracture; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT HAD AN ALLEGED DISSOCIATION OF THE RESURFACING FEMUR AND STEM EXTENSION AND THE BOSS OF THE RESURFACING FEMUR FRACTURED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 TO REVISE THE IMPLANTS TO A COMPRESS SYSTEM, CUSTOM ADAPTOR, AND DISTAL FEMUR IMPLANT. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16383753 ↗
• InjuryOct 30, 2020Appropriate Device Problem Term/Code Not Available

  A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 PERFORMED BY DR. (B)(6) DUE TO SCAR TISSUE FORMING AROUND THE PATIENT'S PATELLA WHICH WAS CAUSING PAIN, STIFFNESS, AND A LOSS OF RANGE OF MOTION OF THE KNEE. THE SURGEON DEBRIDED THE SCAR TISSUE BUT DID NOT REPLACE THE IMPLANTS AS THEY WERE DEEMED TO NOT BE AFFECTED AND THERE WERE NO FAILURES FOUND INTRAOPERATIVELY.

  Patient problems: Scar Tissue

  MAUDE report 10766301 ↗
• 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 10009628 ↗
• InjuryMar 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT UNDERWENT A REVISION SURGERY DUE TO THE RESURFACING FEMUR LOOSENING AND THE RESURFACING FEMUR AND STEM EXTENSION DISSOCIATING.

  Patient problems: No Information

  MAUDE report 9886206 ↗
• InjuryMar 10, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO KNEE PAIN AND UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE FEMUR AND STEM HAD LOOSENED.

  Patient problems: Pain

  MAUDE report 9813782 ↗

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-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-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
• 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