ELEOS Limb Salvage System With BioGrip HC-17120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI B278HC1712003M0), received between Feb 16, 2022 and Feb 23, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT SUFFERED FROM LOOSENING OF THE FEMORAL 17X100MM CEMENTED SEGMENTAL STEM AND ASSOCIATED REDUCED RESECTION COLLAR. THE REVISION SURGERY WAS PERFORMED BY DOCTOR (B)(6) ON (B)(6) 2023. ON 20 FEBRUARY 2024 AND 21 FEBRUARY 2024, ADDITIONAL DETAILS REGARDING THE PRIMARY SURGERY AND PATIENT INFORMATION WERE REQUESTED. ON 21 FEBRUARY 2024, (B)(6) CONFIRMED THAT ADDITIONAL DETAILS WITH RESPECT TO THE PRIMARY SURGERY AND PATIENT INFORMATION REMAIN UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18769231 ↗
• InjuryJul 11, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 DUE TO A SUSPECTED LOOSENING OF THEIR 17X120MM MODULAR COLLAR CEMENTED SEGMENTAL STEM. DURING THE REVISION SURGERY, THE PATIENT'S DISTAL FEMORAL REPLACEMENT SYSTEM WAS REVISED TO A TOTAL FEMORAL REPLACEMENT SYSTEM. DURING THE REVISION SURGERY, THE PATIENT'S MODULAR COLLAR CEMENTED SEGMENTAL STEM WAS EXPLANTED AND A MALE-FEMALE MIDSECTION, MALE-MALE MIDSECTION, AND PROXIMAL FEMUR WERE IMPLANTED. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17302414 ↗
• InjuryNov 11, 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 REMOVED THE IMPLANTS, FLASHED THEM, AND RE-IMPLANTED THE SAME DEVICES. THE FOLLOWING ELEOS IMPLANTS WERE IMPLANTED AT THE TIME OF THE ALLEGED INFECTION: TIBIAL BASEPLATE, CEMENTED SEGMENTAL STEM, DISTAL FEMUR, CEMENTED STEM EXTENSION, MODULAR COLLAR LOCKING RING, MODULAR REDUCED RESECTION COLLAR, TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15780699 ↗
• InjurySep 30, 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 EXPLANTED: TIBIAL BASEPLATE, CEMENTED SEGMENTAL STEM, DISTAL FEMUR, CEMENTED STEM EXTENSION, MODULAR COLLAR LOCKING RING, MODULAR REDUCED RESECTION COLLAR, TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15509560 ↗
• InjuryJun 30, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT EXPERIENCED LOOSENING OF THEIR IMPLANTED ELEOS CEMENTED SEGMENTAL STEM. THE PATIENT WAS REVISED ON (B)(6) 2022 TO REMOVE AND REPLACE THE FOLLOWING DEVICES: ELEOS CEMENTED SEGMENTAL STEM, ELEOS DISTAL FEMUR, ELEOS MALE-FEMALE MIDSECTION, ELEOS BIOGRIP HA COLLAR, DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, AND ELEOS TIBIAL POLYSPACER. THIS EVENT WILL BE CONSIDERED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. NO ISSUES WERE REPORTED WITH THE ELEOS DISTAL FEMUR, ELEOS MALE-FEMALE MIDSECTION, ELEOS BIOGRIP HA COLLAR, DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, AND ELEOS TIBIAL POLYSPACER; THEREFORE, THEY ARE CONSIDERED CONCOMITANT. THIS RECORD CAPTURES THE ELEOS CEMENTED SEGMENTAL STEM.

  Patient problems: Pain

  MAUDE report 14881528 ↗
• InjuryFeb 16, 2022Adverse 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) 2022 DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE SURGEON REVISED THE FOLLOWING ELEOS IMPLANTS: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE SURGEON PERFORMED A WASHOUT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: TIBIAL BASEPLATE, CEMENTED STEM, DISTAL FEMUR, CEMENTED STEM EXTENSION, MODULAR COLLAR LOCKING RING, AND MODULAR REDUCED RESECTION COLLAR. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS NOT BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13546348 ↗