ELEOS Limb Salvage System With BioGrip HC-11120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI B278HC1112003M0), received between Sep 23, 2021 and May 28, 2026 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT AN 81-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION ON (B)(6) 2026 DUE TO LOOSENING OF THE FEMORAL STEM. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening

  MAUDE report 25318158 ↗
• 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 19378098 ↗
• InjuryJul 20, 2023Adverse 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 DUE TO PATELLA BAJA AND FLEXION CONTRACTURE. DURING THE REVISION SURGERY, THE SURGEON IDENTIFIED THAT THE PATIENT HAD DEVELOPED BONE OSTEOPHYTES AND SCAR TISSUE FORMATION. THE SURGEON REMOVED AS MUCH SCAR TISSUE AND BONE OSTEOPHYTES AS POSSIBLE. THE SURGEON REVISED THE DISTAL FEMUR, DISTAL FEMUR AXIAL PIN, TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND MALE-FEMALE MIDSECTION. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: BIOGRIP HA COLLAR, COLLAR LOCKING RING, SEGMENTAL STEM, TIBIAL BASEPLATE, TIBIAL BASEPLATE TAPERED SCREW, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Scar Tissue

  MAUDE report 17364538 ↗
• InjuryJul 5, 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 IMPLANT WAS REVISED: FEMORAL HEAD. A DIFFERENT COMPANY'S BIPOLAR SHELL IMPLANT WAS ALSO REVISED DURING THIS PROCEDURE. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED: PROXIMAL FEMUR, SEGMENTAL STEM, BIOGRIP COLLAR, AND COLLAR LOCKING RING. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17259303 ↗
• InjuryJan 26, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN ELEOS PROXIMAL TIBIA REPLACEMENT PROCEDURE. THE PATIENT WAS REAMED TO PLACE AN ELEOS CEMENTED SEGMENTAL STEM 11MM X 120MM . HOWEVER, THIS STEM COULD NOT BE USED AS THE STERILE BARRIER OF THE PACKAGING WAS COMPROMISED (SEE MFR 3013450937-2023-00003). INSTEAD, AN ELEOS MODULAR COLLAR STEM 11MM X 120MM WAS IMPLANTED. WHILE IMPACTING THE MODULAR COLLAR STEM INTO THE PATIENT, THE PATIENT'S TIBIA FRACTURED. ONCE THE PROCEDURE WAS COMPLETED, IT WAS NOTICED THAT A MODULAR COLLAR WAS NOT IMPLANTED WITH THE MODULAR COLLAR STEM. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY AS THE MODULAR COLLAR STEM WAS IMPLANTED WITHOUT A MODULAR COLLAR, WHICH COULD RESULT IN THE IMPLANT POTENTIALLY LOOSENING POST-OPERATIVELY. THIS REPORT CAPTURES THE ELEOS MODULAR COLLAR STEM.

  Patient problems: Limb Fracture

  MAUDE report 16250802 ↗
• InjuryDec 15, 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 REVISED: DISTAL FEMUR, TWO MALE-FEMALE MIDSECTIONS, TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: BIOGRIP COLLAR, LOCKING RING, SEGMENTAL STEM, TIBIAL BASEPLATE, CANAL-FILLING STEM EXTENSION, AND RESURFACING PATELLA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15990415 ↗
• InjuryNov 23, 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 REVISED THE FOLLOWING ELEOS IMPLANTS: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, DISTAL FEMUR, BIOGRIP COLLAR, COLLAR LOCKING RING, CEMENTED STEM EXTENSION, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15855377 ↗
• InjurySep 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 DUE TO THEIR CEMENTED SEGMENTAL STEM LOOSENING. THE PATIENT'S 11X120MM CEMENTED SEGMENTAL STEM WAS REVISED TO A 13X120MM CEMENTED SEGMENTAL STEM. THE SURGEON ADDITIONALLY REVISED THE BIOGRIP HA COLLAR AND MODULAR COLLAR LOCKING RING. THERE WERE NO REPORTED ISSUES WITH THE BIOGRIP HA COLLAR OR MODULAR COLLAR LOCKING RING. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15338392 ↗
• 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 COMOPENTS AND PERFORMED INCISION AND DRAINAGE. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12523227 ↗