ELEOS™ Limb Salvage System TB-2204E-01MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI B278TB2204E01M0), received between Sep 8, 2021 and Nov 25, 2024 — classified as 4 injuries, 2 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A 65-YEAR-OLD MALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO A DISASSOCIATION OF THE STEM EXTENSION THAT WAS CEMENTED IN THE TIBIA FROM THE REMAINING CONSTRUCT. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON, DOCTOR (B)(6), DECIDED NOT TO USE THE OPTIONAL TIBIAL BASEPLATE TAPERED SCREW DURING THE INDEX SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 20775354 ↗
• InjuryAug 16, 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 AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: DISTAL FEMUR, MALE-FEMALE MIDSECTION, STEM EXTENSION, RESURFACING PATELLA, TIBIAL BASEPLATE, CEMENTED BOWED SEGMENTAL STEM, AND TIBIAL BASEPLATE TAPERED SCREW. THE SURGEON PERFORMED A WASHOUT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17560956 ↗
• InjuryJun 19, 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 IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, TIBIAL POLY SPACER, DISTAL FEMUR, AND TIBIAL HINGE COMPONENT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: STEM EXTENSION, MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17153466 ↗
• InjuryMay 9, 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 IMPLANTS WERE EXPLANTED: TWO CEMENTED STEM EXTENSIONS, TIBIAL HINGE COMPONENT, RESURFACING FEMUR AXIAL PIN, POLY SPACER, TIBIAL BASEPLATE, TIBIAL BASEPLATE TAPERED SCREW, RESURFACING FEMUR, AND RESURFACING FEMUR TAPERED SCREW. THE SURGEON PLACED AN ANTIBIOTIC SPACER. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16899520 ↗
• 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 15079941 ↗
• MalfunctionSep 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PATIENT WAS UNDERGOING A SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6) WHEN THE SURGEON PLACED A TIBIAL BASEPLATE WITHOUT A STEM EXTENSION. WHILE CEMENTING THE TIBIAL BASEPLATE INTO THE PATIENT'S TIBIA, CEMENT STARTED TO EXTRUDE THROUGH THE SCREW HOLE AND OUT OF THE TOP OF THE IMPLANT. THE SURGEON REMOVED THE TIBIAL BASEPLATE INTRAOPERATIVELY AND CLEANED AWAY THE CEMENT. THE TIBIAL BASEPLATE IS PACKAGED WITH A TAPER POLY PLUG WHICH CAN BE OPTIONALLY USED IF A STEM EXTENSION IS NOT BEING IMPLANT. HOWEVER, THE SALES REPRESENTATIVE STATED THAT THERE WAS NO PLUG PACKAGED WITH THE IMPLANT. THE SURGEON WAS ABLE TO PLUG THE TIBIAL BASEPLATE WITH A METAL PLUG AND IMPLANTED THE TIBIAL BASEPLATE SUCCESSFULLY. THE INTRAOPERATIVE ISSUE LED TO A DELAY IN SURGERY OF BETWEEN 10 AND 40 MINUTES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12442386 ↗