ELEOS™ 25002200ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B27825002200E0), received between Dec 19, 2019 and Feb 4, 2022 — classified as 6 injuries, 1 malfunction.

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.

• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; 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. 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 13458660 ↗
• InjuryDec 28, 2021Adverse 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) 2021 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, PROXIMAL TIBIA, CEMENTED BOWED STEM, CEMENTED STRAIGHT STEM, POLY SPACER, DISTAL FEMUR AXIAL PIN, AND TIBIAL HINGE COMPONENT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13095981 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION AND WOUND ISSUES. THE FOLLOWING ELEOS IMPLANTS WERE REMOVED: TIBIAL HINGE COMPONENT, CEMENTED SEGMENTAL STEM (11X152MM), CEMENTED SEGMENTAL STEM (15X152MM), DISTAL FEMUR AXIAL PIN, PROXIMAL TIBIA, DISTAL FEMUR, AND TIBIAL POLY SPACER. THE SURGEON PLACED AN ANTIBIOTIC SPACER. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12508840 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION. THE FOLLOWING PARTS WERE REMOVED AND REVISED: RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: RESURFACING FEMUR, CEMENTED STEM EXTENSION, CEMENTED SEGMENTAL STEM, PROXIMAL TIBIA, AND MALE-FEMALE MIDSECTION. THE SURGEON REMOVED IMPLANTS WITH POLY COMPONENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12164246 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE PATIENT FELL DUE TO AN UNKNOWN REASON WHICH RESULTED IN THEIR INCISION OPENING. DURING THE REVISION SURGERY, THE FOLLOWING IMPLANTS DID NOT APPEAR TO BE DAMAGED: TIBIAL HINGE COMPONENT, CEMENTED STEM 11X152MM, CEMENTED STEM 15X152MM, DISTAL FEMUR AXIAL PIN, PROXIMAL TIBIAL, DISTAL FEMUR, AND TIBIAL POLY SPACER. A WASHOUT WAS PERFORMED AND NO PARTS WERE REPLACED. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED.

  Patient problems: Fall

  MAUDE report 12124893 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; 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 9503707 ↗
• MalfunctionDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH APPRECIABLE MEDIO-LATERAL INSTABILITY.

  Patient problems: No Information

  MAUDE report 9497789 ↗

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-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-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
• 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