ELEOS™ Limb Salvage System TB-2205E-01MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278TB2205E01M0), received between Feb 16, 2022 and Oct 23, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY T. STAMPER, AN ONKOS SALES REPRESENTATIVE, THAT A 59-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION. THE SURGEON, DOCTOR (B)(6), PERFORMED THE WASHOUT AT UNIVERSITY MEDICAL CENTER IN EL PASO, TX.

  Patient problems: Medical device site infection

  MAUDE report 20514092 ↗
• InjuryNov 11, 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 REMOVED THE IMPLANTS, FLASHED THEM, AND RE-IMPLANTED THE SAME DEVICES. THE FOLLOWING ELEOS IMPLANTS WERE IMPLANTED AT THE TIME OF THE ALLEGED INFECTION: TIBIAL BASEPLATE, CEMENTED SEGMENTAL STEM, DISTAL FEMUR, CEMENTED STEM EXTENSION, MODULAR COLLAR LOCKING RING, MODULAR REDUCED RESECTION COLLAR, TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15780713 ↗
• InjurySep 30, 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 EXPLANTED: TIBIAL BASEPLATE, CEMENTED SEGMENTAL STEM, DISTAL FEMUR, CEMENTED STEM EXTENSION, MODULAR COLLAR LOCKING RING, MODULAR REDUCED RESECTION COLLAR, TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15509589 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2022 DUE TO AN ALLEGED INFECTION. THE PATIENT UNDERWENT A POLYSWAP PROCEDURE. THE FOLLOWING IMPLANTS WERE REVISED: ELEOS DISTAL FEMUR, AXIAL PIN, TIBIAL HINGE COMPONENT, SEGMENTAL STEM - CEMENTED, MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, TWO TIBIAL AUGMENTS, STEM EXTENSION - CEMENTED, AND A POLY SPACER. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY DUE TO REVISION SURGERY. THIS RECORD CAPTURES THE ELEOS TIBIAL BASEPLATE.

  Patient problems: Unspecified Infection

  MAUDE report 14120770 ↗
• InjuryFeb 16, 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 ELEOS IMPLANTS: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE SURGEON PERFORMED A WASHOUT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: TIBIAL BASEPLATE, CEMENTED STEM, DISTAL FEMUR, CEMENTED STEM EXTENSION, MODULAR COLLAR LOCKING RING, AND MODULAR REDUCED RESECTION COLLAR. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS NOT BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13546349 ↗