ELEOS™ 2500L004ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI B2782500L004E0), received between Mar 13, 2018 and Feb 15, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

• 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 16383752 ↗
• 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 14439199 ↗
• InjuryFeb 4, 2022Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ALLEGED DISASSOCIATED STEM ON THE RESURFACING FEMUR AND AN ALLEGED INFECTION ON (B)(6) 2022, AFTER RECEIVING A PROXIMAL TIBIA REPLACEMENT SURGERY ON (B)(6) 2020. THE IMPLANTING SURGEON PERFORMED REVISION SURGERIES ON THE PATIENT TO WASH THE PATIENT OUT ON (B)(6) 2022 AND (B)(6) 2022. THE SURGEON ALSO PERFORMED A REVISION SURGERY ON (B)(6) 2022 TO REMOVE ALL THE IMPLANTS THAT WERE IMPLANTED ON (B)(6) 2020 DURING THE ORIGINAL THE PROXIMAL TIBIA REPLACEMENT SURGERY. IT WAS ALSO REPORTED THAT THE SURGEON PLANS TO PUT IN REPLACEMENT IMPLANTS WHEN THE INFECTION CLEARS UP. NO REVISION SURGERY TO DO THIS HAS BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13458658 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH A SUBLUXING PATELLA, WHICH REQUIRED SURGICAL INTERVENTION.

  Patient problems: Joint Dislocation

  MAUDE report 9765154 ↗
• InjuryDec 19, 2019Loss of Osseointegration; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  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 9497759 ↗
• InjuryMar 13, 2018Fracture; Loss of Osseointegration; Detachment of Device or Device Component; Fracture; Loss of Osseointegration; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED ON ELEOS RESURFACING HINGE KNEE WHERE IT APPEARED ON X-RAYS THAT THE FEMORAL COMPONENT HAD DISSOCIATED FROM THE STEM EXTENSION. UPON REMOVAL OF THE COMPONENTS, IT WAS DISCOVERED THAT THE RESURFACING FEMUR HAD LOOSENED AND THE WALL OF THE FEMALE BOSS HAD FRACTURED ON ONE SIDE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 7334929 ↗

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-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