ELEOS Limb Salvage System SB-4044V-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B278SB4044V03M0), received between Feb 16, 2022 and Nov 11, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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.

  Patient problems: Unspecified Infection

  MAUDE report 15780714 ↗
• 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 15509690 ↗
• 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 13546350 ↗