ELEOS Limb Salvage System CS-11120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278CS1112003M0), received between Oct 28, 2021 and Jan 20, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2022, IT WAS IDENTIFIED THAT THE INNER TRAY OF THE CEMENTED STRAIGHT SEGMENTAL STEM WAS NO LONGER SEALED, HOWEVER, THE OUTER TRAY WAS STILL SEALED. THE SURGEON IMPLANTED A DIFFERENT CEMENTED SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS MALFUNCTION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218476 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 DUE TO AN ALLEGED INFECTION. THE PATIENT'S INDEX SURGERY OCCURED ON (B)(6) 2021 WHERE THE PATIENT WAS IMPLANTED WITH THE FOLLOWING IMPLANTS: ELEOS PROXIMAL TIBIA, ELEOS RESURFACING FEMUR AXIAL PIN, ELEOS POLY SPACER, ELEOS TIBIAL HINGE, ELEOS SEGMENTAL STEM, ELEOS STEM EXTENSION, AND ELEOS RESURFACING FEMUR. DURING THE REVISION PROCEDURE, THE ELEOS PROXIMAL TIBIA, ELEOS RESURFACING FEMUR AXIAL PIN, ELEOS POLY SPACER, AND ELEOS TIBIAL HINGE WERE REMOVED AND REPLACED. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY, AS THE PATIENT UNDERWENT A REVISION PROCEDURE. ALL THE DEVICES IMPLANTED AT THE TIME OF INFECTION WILL BE REPORTED. THIS REPORT CAPTURES THE ELEOS SEGMENTAL STEM.

  Patient problems: Unspecified Infection

  MAUDE report 15827255 ↗
• MalfunctionAug 31, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2022, IT WAS IDENTIFIED THAT THE PACKAGING OF THE CEMENTED SEGMENTAL STEM WAS DAMAGED AND NO LONGER SEALED. UPON OPENING THE BOX, THIS MALFUNCTION WAS IDENTIFIED AND THE DEVICE WAS NOT USED. THE SURGEON IMPLANTED A DIFFERENT SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS MALFUNCTION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332503 ↗
• MalfunctionJun 16, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2022, IT WAS IDENTIFIED THAT THE PACKAGING OF THE CEMENTED SEGMENTAL STEM WAS DAMAGED AND NO LONGER SEALED. UPON OPENING THE BOX, THIS MALFUNCTION WAS IDENTIFIED AND THE DEVICE WAS NOT USED. THE SURGEON IMPLANTED A DIFFERENT SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS MALFUNCTION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14719698 ↗
• InjuryOct 28, 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 PATIENT'S KNEE WAS DISCHARGING FLUID AND THE SURGEON WANTED TO TEST FOR AN INFECTION. DURING THE REVISION SURGERY, THE SURGEON PERFORMED A POLY SWAP AND A WASHOUT. THE FOLLOWING ELEOS IMPLANTS WERE REVISED DURING THE REVISION SURGERY: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, MALE-FEMALE MIDSECTION, CEMENTED SEGMENTAL STEM, TIBIAL BASEPLATE, CEMENTED STEM EXTENSION, AND RESURFACING PATELLA. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 12712515 ↗

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