ELEOS Limb Salvage System HR-30001-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI B278HR3000103M0), received between Jul 21, 2022 and Feb 18, 2026 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 79-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO A FALL. THIS REPORT CAPTURES ELEOS MODULAR COLLAR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Periprosthetic fracture

  MAUDE report 24381242 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ONKOS SALES REPRESENTATIVE REPORTED A REVISION SURGERY WHICH TOOK PLACE ON (B)(6) 2025 DUE TO AN ALLEGED PERIPROSTHETIC JOINT INFECTION IN AN 85-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT.

  Patient problems: Medical device site infection

  MAUDE report 21979052 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4), AN ONKOS DISTRIBUTOR, THAT A 43-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF THE ELEOS CEMENTED SEGMENTAL STEM THAT WAS INSERTED INTO THE FEMUR WITHOUT THE USE OF BONE CEMENT. THE REPORTED INFORMATION ALSO INDICATED THAT THE ELEOS TIBIAL BASEPLATE WAS ALSO INSERTED WITHOUT BONE CEMENT AND THE SURGEON SUSPECTED THAT THE PATIENT HAD A PERI-OPERATIVE INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 20475678 ↗
• InjuryJul 20, 2023Adverse 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 PATELLA BAJA AND FLEXION CONTRACTURE. DURING THE REVISION SURGERY, THE SURGEON IDENTIFIED THAT THE PATIENT HAD DEVELOPED BONE OSTEOPHYTES AND SCAR TISSUE FORMATION. THE SURGEON REMOVED AS MUCH SCAR TISSUE AND BONE OSTEOPHYTES AS POSSIBLE. THE SURGEON REVISED THE DISTAL FEMUR, DISTAL FEMUR AXIAL PIN, TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND MALE-FEMALE MIDSECTION. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: BIOGRIP HA COLLAR, COLLAR LOCKING RING, SEGMENTAL STEM, TIBIAL BASEPLATE, TIBIAL BASEPLATE TAPERED SCREW, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Scar Tissue

  MAUDE report 17364541 ↗
• InjuryJul 5, 2023Adverse 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) 2023 WHERE THE FOLLOWING ELEOS IMPLANT WAS REVISED: FEMORAL HEAD. A DIFFERENT COMPANY'S BIPOLAR SHELL IMPLANT WAS ALSO REVISED DURING THIS PROCEDURE. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED: PROXIMAL FEMUR, SEGMENTAL STEM, BIOGRIP COLLAR, AND COLLAR LOCKING RING. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17257666 ↗
• InjuryDec 15, 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: DISTAL FEMUR, TWO MALE-FEMALE MIDSECTIONS, TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: BIOGRIP COLLAR, LOCKING RING, SEGMENTAL STEM, TIBIAL BASEPLATE, CANAL-FILLING STEM EXTENSION, AND RESURFACING PATELLA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15990459 ↗
• InjuryNov 23, 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 SURGEON REVISED THE FOLLOWING ELEOS IMPLANTS: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, DISTAL FEMUR, BIOGRIP COLLAR, COLLAR LOCKING RING, CEMENTED STEM EXTENSION, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15855372 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE FOLLOWING IMPLANTS WERE REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP AND ELEOS TIBIAL POLY SPACER.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15555571 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY. THE FOLLOWING IMPLANTS WERE REMOVED AND REPLACED DURING THE REVISION: ELEOS TIBIAL HINGE, ELEOS TIBIAL POLY SPACER, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR AND 2 X ELEOS MALE-FEMALE MIDSECTIONS. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15079943 ↗