ELEOS Limb Salvage System With BioGrip HC-13120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278HC1312003M0), received between Oct 19, 2021 and Dec 1, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4), AN ONKOS SALES REPRESENTATIVE, THAT A 59-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO LOOSENING OF SEGMENTAL 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 23687660 ↗
• InjuryDec 26, 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 70-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION ON (B)(6) 2024 DUE TO LOOSENING OF THE ELEOS CANAL FILLING SEGMENTAL STEM THAT WAS INSERTED INTO THE FEMUR.

  Patient problems: Aseptic loosening

  MAUDE report 21020744 ↗
• MalfunctionMar 7, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING AN ELEOS PROXIMAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2022, THE SURGEON IMPLANTED THE ELEOS MODULAR COLLAR CEMENTED STEM WITHOUT A ELEOS MODULAR COLLAR OR ELEOS COLLAR LOCKING RING. THIS TYPE OF STEM IS INTENDED TO BE IMPLANTED WITH A MODULAR COLLAR AND COLLAR LOCKING RING. NO ADVERSE EVENTS HAVE BEEN REPORTED FROM THIS MALFUNCTION. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497048 ↗
• MalfunctionMar 6, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROXIMAL 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. NO ADVERSE EVENTS HAVE BEEN REPORTED FROM THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492255 ↗
• 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 12655974 ↗