ELEOS™ Limb Salvage System RF-R004E-01MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B278RFR004E01M0), received between Feb 19, 2022 and Nov 1, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO AN ALLEGED INFECTION. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2022 WITH THE FOLLOWING ELEOS IMPLANTS: STEM EXTENSION, RESURFACING AXIAL PIN, STRAIGHT CEMENTED STEM, RESURFACING FEMUR, PROXIMAL TIBIA, TIBIAL HINGE W/ ROTATIONAL STOP, RESURFACING FEMUR TAPERED SCREW, AND A POLY SPACER. ON (B)(6) 2022 THE PATIENT WAS REVISED TO REMOVE AND REPLACE THE AXIAL PIN, TIBIAL HINGE, AND POLY SPACER. THE REMAINING DEVICES WERE LEFT IMPLANTED IN THE PATIENT. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO REVISION PROCEDURE. ALL DEVICES WHICH WERE IMPLANTED AT THE TIME OF THE ALLEGED INFECTION WILL BE REPORTED. THIS RECORD CAPTURES THE ELEOS RESURFACING FEMUR.

  Patient problems: Unspecified Infection

  MAUDE report 15711892 ↗
• InjuryFeb 19, 2022Adverse 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) 2022 DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE SURGEON REVISED THE FOLLOWING IMPLANTS: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER, AND GUARDIAN RESURFACING FEMUR AXIAL PIN. THE SURGEON PERFORMED A WASHOUT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: TIBIAL BASEPLATE, CEMENTED STEM EXTENSION (18X100MM), CEMENTED STEM EXTENSION (16X65MM), RESURFACING FEMUR, TIBIAL BASEPLATE TAPERED SCREW, AND RESURFACING FEMUR TAPERED SCREW. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS NOT BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13565387 ↗