ELEOS Limb Salvage System With BioGrip HC-15120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B278HC1512003M0), received between Jul 21, 2022 and Nov 28, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO LOOSENING OF THE SEGMENTAL STEM AND COLLAR. CEMENT DID NOT BOND TO STEM AND NO GROWTH ON COLLAR. THIS REPORT CAPTURES ELEOS CEMENTED STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening

  MAUDE report 23673951 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY D. HARDARDT, AND ONKOS SALES REPRESENTATIVE THAT A 33-YEAR-OLD MALE PATIENT WITH AN ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY AND NEEDED A CHANGE IN CONSTRUCT. CONVERTED THEIR RESURFACING FEMUR WITH PTR TO A DTR/PTR. REVISED ELEOS STEM FOR LOOSENING IN TIBIA. THIS REPORT CAPTURES THE ELEOS CANAL FILLING SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening

  MAUDE report 22890797 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ONKOS SALES REPRESENTATIVE REPORTED A REVISION SURGERY WHICH TOOK PLACE ON (B)(6) 2025 DUE TO AN ALLEGED PERIPROSTHETIC JOINT INFECTION IN AN 85-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT.

  Patient problems: Medical device site infection

  MAUDE report 21979054 ↗
• InjuryOct 17, 2024Loss of or Failure to Bond; Unstable; Loss of or Failure to Bond; Unstable

  IT WAS REPORTED BY (B)(4), AN ONKOS DISTRIBUTOR, THAT A 43-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF THE ELEOS CEMENTED SEGMENTAL STEM THAT WAS INSERTED INTO THE FEMUR WITHOUT THE USE OF BONE CEMENT. THE REPORTED INFORMATION ALSO INDICATED THAT THE ELEOS TIBIAL BASEPLATE WAS ALSO INSERTED WITHOUT BONE CEMENT AND THE SURGEON SUSPECTED THAT THE PATIENT HAD A PERI-OPERATIVE INFECTION.

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 20475665 ↗
• 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 15677488 ↗
• MalfunctionOct 14, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A DISTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2022, THE SURGEON IMPLANTED THE MODULAR COLLAR CEMENTED STEM WITHOUT A MODULAR COLLAR OR COLLAR LOCKING RING. THIS TYPE OF STEM IS INTENDED TO BE IMPLANTED WITH A MODULAR COLLAR AND COLLAR LOCKING RING. IT WAS REPORTED THAT THE SURGEON ACHIEVED GOOD FIXATION WHEN IMPLANTING THE STEM. NO ADVERSE EVENTS HAVE BEEN REPORTED FROM THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610746 ↗
• 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 15079965 ↗