ELEOS™ 2500L003ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI B2782500L003E0), received between Jan 9, 2019 and Mar 3, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 reports).

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, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (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 RESURFACING FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481948 ↗
• InjuryFeb 9, 2022Fracture; Loose or Intermittent Connection; Fracture; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 DUE TO THE BOSS OF THE RESURFACING FEMUR CRACKING. THIS FRACTURE RESULTED IN AN INCOMPLETE SURFACE TO ACCEPT THE MORSE TAPER OF THE STEM EXTENSION RESULTING IN THE TWO IMPLANTS DISSOCIATING. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: RESURFACING FEMUR, RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13501765 ↗
• MalfunctionOct 9, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 PERFORMED BY DR. (B)(6) DUE TO DISSOCIATION OF THE RESURFACING FEMUR COMPONENT AND FEMORAL STEM EXTENSION COMPONENT. DURING THE REVISION, THE SURGEON REPLACED THE RESURFACING FEMUR COMPONENT, THE RESURFACING FEMUR AXIAL PIN, AND THE STEM EXTENSION COMPONENT WITH A DISTAL FEMUR COMPONENT, DISTAL FEMUR AXIAL PIN, AND A SEGMENTAL STEM COMPONENT RESPECTIVELY. THE SURGEON ALSO REPLACED A TIBIAL HINGE COMPONENT DURING THE REVISION.

  Patient problems: Insufficient Information

  MAUDE report 10659088 ↗
• InjurySep 2, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISSOCIATION OF THE RESURFACING FEMUR COMPONENT AND THE STEM EXTENSION COMPONENT THAT WERE IMPLANTED IN THEIR LEFT LEG BY (B)(6), HIGHLANDS ON (B)(6) 2020. THE RESURFACING FEMUR COMPONENT WAS EXPLANTED AND REPLACED. THE STEM EXTENSION COMPONENT WAS LEFT IN PLACE.

  Patient problems: Pain

  MAUDE report 10483145 ↗
• InjuryDec 20, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A REVISION SURGERY DUE TO A DEEP LATE INFECTION. UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE RESURFACING FEMUR AND STEM EXTENSION DISSOCIATED.

  Patient problems: No Information; Unspecified Infection

  MAUDE report 9503710 ↗
• InjuryJan 9, 2019Loss of Osseointegration; Detachment of Device or Device Component; Loss of Osseointegration; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED DUE TO A FAILED TOTAL KNEE, WHERE THE RESURFACING FEMUR LOOSENED, AND THE RESURFACING FEMUR AND STEM EXTENSION DISSOCIATED. ADDITIONALLY, IT WAS INDICATED THAT THE PATIENT HAD A POSSIBLE INFECTION.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 8231482 ↗

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-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-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
• 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