ELEOS™ 25000051ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B27825000051E0), received between Apr 6, 2021 and Apr 27, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 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 TO WASHOUT THEIR PROXIMAL FEMORAL REPLACEMENT SYSTEM. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY TO WASHOUT THEIR DISTAL FEMORAL REPLACEMENT SYSTEM AND REVISE THE TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL FEMUR AXIAL PIN. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY WHERE ALL IMPLANTS WERE REVISED. THE FOLLOWING IMPLANTS WERE REVISED: MALE-MALE MIDSECTION, MALE-FEMALE MIDSECTION, POLY SPACER, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, PROXIMAL FEMUR, AND DISTAL FEMUR. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 14228986 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR-OLD FEMALE PATIENT WAS EXPERIENCING PAIN IN HER HIP AFTER MULTIPLE REVISION SURGERIES HAD BEEN PERFORMED OVER THE PAST YEAR. THIS ISSUE STARTED ON (B)(6) 2021. SCAR TISSUE HAD DEVELOPED IN THE SOFT TISSUE CAVITY FROM THE PREVIOUS SURGERIES. THE SURGEON, DR. (B)(6), DECIDED THAT THE PATIENT'S SEGMENTS SHOULD BE SHORTENED TO RELIEVE THE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHERE A 60MM MALE-FEMALE MIDSECTION WAS REMOVED AND REPLACED WITH A 40MM MALE-FEMALE MIDSECTION AND A 50MM MALE-MALE MIDSECTION WAS REMOVED AND REPLACED WITH A 40MM MALE-MALE MIDSECTION. THE PRIMARY ELEOS SURGERY, WHICH WAS PERFORMED FOR UNKNOWN REASONS, WAS PERFORMED ON (B)(6) 2020 TO PLACE A TOTAL FEMUR SYSTEM. THE PATIENT HAD A PROXIMAL FEMUR IMPLANT AND A MALE-FEMALE MIDSECTION REVISED DURING HER PREVIOUS REVISION SURGERY WHICH OCCURRED ON (B)(6) 2020. DURING THE REVISION ON (B)(6) 2021, A 50MM MALE-MALE MIDSECTION WAS REPLACED WITH A 40MM MALE-FEMALE MIDSECTION. A 40MM MALE-FEMALE MIDSECTION AND A PROXIMAL FEMUR WERE REPLACED WITH THE SAME SIZED IMPLANTS. A 60MM MALE-FEMALE MIDSECTION WAS PRESENT DURING THE REVISION BUT WAS NOT REVISED. IT IS BELIEVED THAT THE PATIENT HAS A MICRO

  Patient problems: Scar Tissue

  MAUDE report 11624511 ↗

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-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-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-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