ELEOS Limb Salvage System HR-30000-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI B278HR3000003M0), received between Sep 23, 2021 and May 22, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AN ONKOS DISTRIBUTOR, THAT A 34-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT AND CUSTOM PROXIMAL TIBIA UNDERWENT A REVISION SURGERY ON (B)(6) 2024 TO REMOVE ALL IMPLANTED HARDWARE AND PERFORM AN ABOVE THE KNEE AMPUTATION THE OPERATIVE LEG DUE TO A CHRONIC INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 19378088 ↗
• 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 15780720 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF MOBILITY IN THEIR KNEE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION SURGERY, THE SURGEON IDENTIFIED SCAR TISSUE FORMATION. THE SURGEON REMOVED THE SCAR TISSUE. THE SURGEON TOOK OUT ALL OF THE IMPLANTS BESIDES THE SEGMENTAL STEM, COLLAR, LOCKING RING, AND TIBIAL BASEPLATE, AND FLASHED THESE DEVICES THEN RE-IMPLANTED THE DEVICES. THE SURGEON SCHEDULED ANOTHER REVISION SURGERY ON (B)(6) 2022 IN ORDER TO REVISE SOME IMPLANTS AND PERFORM A WASHOUT IN ORDER TO PREVENT AN INFECTION. ON (B)(6) 2022, THE SURGEON REVISED THE FOLLOWING IMPLANTS: DISTAL FEMUR AXIAL PIN, POLY SPACER, TIBIAL HINGE COMPONENT, DISTAL FEMUR, AND MALE-FEMALE MIDSECTION. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 15677487 ↗
• 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 15509591 ↗
• 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 13546352 ↗
• InjuryNov 6, 2021Adverse 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 AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: RESURFACING FEMUR AXIAL PIN, POLY SPACER, AND TIBIAL HINGE COMPONENT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY: CEMENTED STEM EXTENSION, BIOGRIP COLLAR, COLLAR LOCKING RING, RESURFACING FEMUR, CEMENTED STEM, AND PROXIMAL TIBIA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12755827 ↗
• InjuryOct 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE PATIENT FELL FOR AN UNKNOWN REASON WHICH CAUSED SOFT TISSUE DAMAGE TO THE SURROUNDING STRUCTURES OF THE KNEE. DURING THE REVISION SURGERY, THE SURGEON PERFORMED A SOFT TISSUE REPAIR. A SEGMENTAL STEM WAS REQUESTED FOR THE REVISION SURGERY BUT WAS NOT IMPLANTED. NO ELEOS IMPLANTS WERE REVISED DURING THE REVISION SURGERY. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN MADE AVAILABLE.

  Patient problems: Fall; Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12655975 ↗
• InjurySep 23, 2021Adverse 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) 2021 DUE TO AN ALLEGED INFECTION. THE FOLLOWING PART WERE REMOVED AND REVISED: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: TIBIAL BASEPLATE, DISTAL FEMUR, STEM EXTENSION, COLLAR, COLLAR LOCKING RING, AND CEMENTED STEM . THE SURGEON REMOVED IMPLANTS WITH POLY COMPONENTS AND PERFORMED INCISION AND DRAINAGE. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12523080 ↗