ELEOS Limb Salvage System With BioGrip PB-2400R-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B278PB2400R03M0), received between Oct 19, 2021 and Oct 6, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 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 ON (B)(6) 2022. THE FOLLOWING IMPLANTS WERE REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP AND ELEOS TIBIAL POLY SPACER.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15555580 ↗
• 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 WAHOUT 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 12755854 ↗
• 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 12655971 ↗