ELEOS Limb Salvage System With BioGrip PB-3200R-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI B278PB3200R03M0), received between Jul 21, 2022 and Oct 17, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Medical device site infection

  MAUDE report 20476291 ↗
• 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 15990499 ↗
• 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 15677486 ↗
• 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 15079961 ↗