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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI B278RFTSCRW01M0), received between Feb 19, 2022 and Dec 30, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 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 71-YEAR-OLD FEMALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21036106 ↗
• 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 16899526 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH ONKOS DEVICES ON (B)(6) 2022. AN ONKOS CUSTOM ADAPTOR WAS CREATED TO CONNECT TO THE PATIENT'S PREVIOUSLY EXISTING HARDWARE TO THE ONKOS DISTAL FEMUR REPLACEMENT SYSTEM. IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2022 DUE TO AN INFECTION. THE FOLLOWING IMPLANTED DEVICES WERE REMOVED DURING THE REVISION PROCEDURE: CUSTOM COMPRESS ADAPTOR, ELEOS TIBIAL HINGE, ELEOS TIBIAL POLY SPACER, ELEOS TIBIAL BASEPLATE, ELEOS TIBIAL BASEPLATE TAPERED SCREW, TWO ELEOS MALE-FEMALE MIDSECTIONS, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR, AND AN ELEOS TIBIAL BASEPLATE. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 14649561 ↗
• 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 13565384 ↗