ELEOS Limb Salvage System With BioGrip PB-2800R-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278PB2800R03M0), received between Nov 23, 2022 and Feb 18, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 79-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO A FALL.THIS REPORT CAPTURES ELEOS HA COLLAR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Periprosthetic fracture

  MAUDE report 24381245 ↗
• 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 19378101 ↗
• 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 17364549 ↗
• InjuryJul 6, 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 17264148 ↗
• 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 15855389 ↗