ELEOS Limb Salvage System CB-15152-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B278CB1515203M0), received between Jul 6, 2021 and Apr 9, 2024 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Unstable” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Unstable; Unstable

  A REVISION SURGERY THAT OCCURRED ON (B)(6) 2024 WAS DISCOVERED DURING THE INVESTIGATION OF AN UNRELATED COMPLAINT. THIS COMPLAINT REPORT WAS SUBSEQUENTLY INITIATED TO INVESTIGATE. INFORMATION ABOUT THE REVISION THAT TOOK PLACE ON (B)(6) 2024 WAS PROVIDED BY (B)(6), AN ONKOS SALES REPRESENTATIVE. (B)(6) REPORTED THAT THE 66-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL TIBIA AND DISTAL FEMUR REPLACEMENT UNDERWENT THE REVISION SURGERY TO ADDRESS AN ALLEGED LOOSENING OF THE FEMORAL SEGMENTAL STEM. THE CEMENTED SEGMENTAL STEM WAS REMOVED AND REPLACED ALONG WITH SEVERAL OTHER ELEOS DEVICES THAT WERE COMPONENTS OF THE PROSTHETIC CONSTRUCT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19072732 ↗
• DeathJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CANCER PATIENT. PATIENT EXPERIENCED AN EMBOLISM IN CANAL AFTER STEM WAS CEMENTED IN FEMUR. THE PATIENT CRASHED AND PASSED AWAY ON THE TABLE DURING THE SURGERY.

  Patient problems: Embolism/Embolus

  MAUDE report 18534753 ↗
• InjuryAug 16, 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 AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: DISTAL FEMUR, MALE-FEMALE MIDSECTION, STEM EXTENSION, RESURFACING PATELLA, TIBIAL BASEPLATE, CEMENTED BOWED SEGMENTAL STEM, AND TIBIAL BASEPLATE TAPERED SCREW. THE SURGEON PERFORMED A WASHOUT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17560962 ↗
• InjuryDec 28, 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. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, PROXIMAL TIBIA, CEMENTED BOWED STEM, CEMENTED STRAIGHT STEM, POLY SPACER, DISTAL FEMUR AXIAL PIN, AND TIBIAL HINGE COMPONENT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13095899 ↗
• InjuryNov 18, 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. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, DISTAL FEMUR, TIBIAL HINGE COMPONENT, POLY SPACER, 50MM MALE-FEMALE MIDSECTION, AND 110MM MALE-FEMALE MIDSECTION. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CEMENTED BOWED STEM, TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION. NO FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12840479 ↗
• InjurySep 21, 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 AND WOUND ISSUES. THE FOLLOWING ELEOS IMPLANTS WERE REMOVED: TIBIAL HINGE COMPONENT, CEMENTED SEGMENTAL STEM (11X152MM), CEMENTED SEGMENTAL STEM (15X152MM), DISTAL FEMUR AXIAL PIN, PROXIMAL TIBIA, DISTAL FEMUR, AND TIBIAL POLY SPACER. THE SURGEON PLACED AN ANTIBIOTIC SPACER. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12508838 ↗
• InjuryJul 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. THE PATIENT FELL DUE TO AN UNKNOWN REASON WHICH RESULTED IN THEIR INCISION OPENING. DURING THE REVISION SURGERY, THE FOLLOWING IMPLANTS DID NOT APPEAR TO BE DAMAGED: TIBIAL HINGE COMPONENT, CEMENTED STEM 11X152MM, CEMENTED STEM 15X152MM, DISTAL FEMUR AXIAL PIN, PROXIMAL TIBIAL, DISTAL FEMUR, AND TIBIAL POLY SPACER. A WASHOUT WAS PERFORMED AND NO PARTS WERE REPLACED. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED.

  Patient problems: Fall

  MAUDE report 12124887 ↗

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-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-2423-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. 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-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-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-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-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-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-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
• 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