ELEOS Limb Salvage System CS-17120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI B278CS1712003M0), received between Jul 24, 2019 and Jul 14, 2025 — classified as 1 death, 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

11 other recalls cover devices cleared under the same FDA submission (K161520); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 78-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF THE FEMORAL STEM. THIS REPORT CAPTURES THE ELEOS CEMENTED STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening

  MAUDE report 22496866 ↗
• InjuryMar 13, 2025Adverse 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 77-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF THE FEMORAL STEM.

  Patient problems: Aseptic loosening

  MAUDE report 21597260 ↗
• InjuryMar 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REVISION SURGERY INVESTIGATED VIA THE CURRENT REPORT OCCURRED ON (B)(6) 2023. AT THE TIME OF THE REVISION SURGERY, THE THEN 47-YEAR-OLD FEMALE PATIENT WAS IMPLANTED WITH ELEOS DEVICES MATCHING THE PART NUMBERS IDENTIFIED IN THE TABLE ABOVE. THE EXPLANTED DEVICE INFORMATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18906035 ↗
• InjuryMay 30, 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 AND EXTENSOR MECHANISM DISRUPTION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: CEMENTED SEGMENTAL STEM, TWO MALE FEMAL MIDSECTIONS, DISTAL FEMUR, POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. THE DATE OF THE PATIENT'S INDEX ELEOS SURGERY IS UNKNOWN AND THE IMPLANTS PLACED DURING THIS PROCEDURE ARE UNKNOWN. THEREFORE, IT IS UNKNOWN IF THERE WERE ADDITIONAL IMPLANTS AT THE TIME OF THIS PATIENT'S ALLEGED INFECTION AND EXTENSOR MECHANISM DISRUPTION. ATTEMPTS WERE MADE AND NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 17025308 ↗
• InjuryDec 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PATIENT WAS IMPLANTED WITH THE ELEOS PROXIMAL TIBIA REPLACEMENT SYSTEM ON (B)(6) 2019. ON (B)(6) 2022, OVER TWO YEARS POST-OPERATIVELY, THE PATIENT WAS REVISED. IT WAS REPORTED THAT THE PATIENT'S ELEOS STRAIGHT CEMENTED STEM HAD DISSOCIATED FROM THE ELEOS RESURFACING FEMUR. THE FOLLOWING IMPLANTS WERE IMPLANTED ON (B)(6) 2019: ELEOS MALE-FEMALE MIDSECTION, ELEOS CEMENTED STRAIGHT STEM, ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER, ELEOS PROXIMAL TIBIA, ELEOS RESURFACING FEMUR, ELEOS RESURFACING FEMUR AXIAL PIN, AND ELEOS STEM EXTENSION. DURING THE PATIENT'S REVISION SURGERY ON (B)(6) 2022 THE FOLLOWING IMPLANTS WERE PLACED: ELEOS STEM EXTENSION, ELEOS TIBIAL POLY SPACER, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR, ELEOS SEGMENTAL STEM, ELEOS LOCKING RING, ELEOS MALE FEMAL MIDSECTION, AND ELEOS TIBIAL HINGE. NO ISSUES WERE REPORTED AGAINST THE REMAINING DEVICES. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY. THIS REPORT CAPTURES THE DISSOCIATED ELEOS RESURFACING FEMUR.

  Patient problems: Insufficient Information

  MAUDE report 16038568 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS DISCOVERED ON (B)(6) 2022, THROUGH PCR 08052022-1, THAT A PATIENT UNDERWENT A PRIOR REVISION SURGERY DUE TO INFECTION ON (B)(6) 2021. THE PATIENT'S INDEX PROCEDURE OCCURED ON 11/19/2021. DURING THE REVISION PROCEDURE, THE ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL POLY SPACER, AND ELEOS TIBIAL HINGE W/ ROTATIONAL STOP WERE REMOVED AND REPLACED. THE FOLLOWING DEVICES REMAIN IMPLANTED: ELEOS CEMENTED STRAIGHT SEGMENTAL STEM, ELEOS TIBIAL BLOCK AUGMENT, ELEOS DISTAL FEMUR, ELEOS TIBIAL BASEPLATE, ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY DUE TO REVISION SURGERY. THIS RECORD CAPTURES THE ELEOS CEMENTED STRAIGHT SEGMENTAL STEM.

  Patient problems: Unspecified Infection

  MAUDE report 15526013 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2022 DUE TO AN ALLEGED INFECTION. THE PATIENT UNDERWENT A POLYSWAP PROCEDURE. THE FOLLOWING IMPLANTS WERE REVISED: ELEOS DISTAL FEMUR, AXIAL PIN, TIBIAL HINGE COMPONENT, SEGMENTAL STEM - CEMENTED, MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, TWO TIBIAL AUGMENTS, STEM EXTENSION - CEMENTED, AND A POLY SPACER. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY DUE TO REVISION SURGERY. THIS RECORD CAPTURES THE ELEOS CEMENTED SEGEMENTAL STEM.

  Patient problems: Unspecified Infection

  MAUDE report 14120767 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SCHEDULED A REVISION SURGERY ON (B)(6) 2022 FOR A POLY SWAP AFTER HAVING A DISTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2021. THE REVISION SURGERY WAS CANCELLED AND HAS NOT BEEN RESCHEDULED. IT WAS CANCELLED DUE TO ALLEGED PATIENT ILLNESS. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13447630 ↗
• InjuryDec 6, 2021Adverse 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) 2021 DUE TO AN ALLEGED INFECTION. THE SURGEON REVISED THE FOLLOWING ELEOS COMPONENTS: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, CEMENTED STEM EXTENSION, CEMENTED SEGMENTAL STEM, AND TIBIAL BASEPLATE. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12933271 ↗
• DeathJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT FRACTURED BOTH OF THEIR DISTAL FEMURS AND REQUIRED A BILATERAL DISTAL FEMUR REPLACEMENT. SHORTLY AFTER THE IMPLANTS WERE PLACED THE PATIENT PASSED AWAY.

  Patient problems: Death

  MAUDE report 8823558 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161520. One submission often covers many models, so check the product and lot details in each record.

• Z-2423-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
• Z-2424-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
• Z-2425-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
• Z-1857-2025 · Sep 22, 2024 · Open, Classified
  ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
• Z-1881-2025 · Sep 1, 2023 · Open, Classified
  Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03
• Z-1882-2025 · Sep 1, 2023 · Open, Classified
  Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, F
• Z-1879-2025 · Sep 1, 2023 · Open, Classified
  a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M,
• Z-1884-2025 · Sep 1, 2023 · Open, Classified
  Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model
• Z-2648-2017 · May 23, 2017 · Terminated
  ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
• Z-2647-2017 · May 23, 2017 · Terminated
  ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
• Z-2646-2017 · May 23, 2017 · Terminated
  ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E