ELEOS Limb Salvage System CS-15120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI B278CS1512003M0), received between Jul 24, 2019 and Nov 11, 2025 — classified as 1 death, 9 injuries.

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.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23526914 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HISTORICAL REVISION OF AN ELEOS DISTAL FEMUR REPLACEMENT WAS REPORTEDLY DUE TO AN ALLEGED PERI-PROSTHETIC JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 22063376 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AN ONKOS DISTRIBUTOR, THAT A 43-YEAR-OLD FEMALE PATIENT WITH AN UNDERWENT REVISION DUE TO LOOSENING OF THE FEMORAL STEM AND DISLOCATION OF THE KNEE JOINT.

  Patient problems: Aseptic loosening

  MAUDE report 21568689 ↗
• InjuryMar 27, 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. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS REMAINED IMPLANTED DURING THE REVISION SURGERY: SEGMENTAL STEM, TIBIAL BASEPLATE, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16624616 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO AN ALLEGED INFECTION. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2022 WITH THE FOLLOWING ELEOS IMPLANTS: STEM EXTENSION, RESURFACING AXIAL PIN, STRAIGHT CEMENTED STEM, RESURFACING FEMUR, PROXIMAL TIBIA, TIBIAL HINGE W/ ROTATIONAL STOP, RESURFACING FEMUR TAPERED SCREW, AND A POLY SPACER. ON (B)(6) 2022 THE PATIENT WAS REVISED TO REMOVE AND REPLACE THE AXIAL PIN, TIBIAL HINGE, AND POLY SPACER. THE REMAINING DEVICES WERE LEFT IMPLANTED IN THE PATIENT. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO REVISION PROCEDURE. ALL DEVICES WHICH WERE IMPLANTED AT THE TIME OF THE ALLEGED INFECTION WILL BE REPORTED. THIS RECORD CAPTURES THE ELEOS CEMENTED STEM.

  Patient problems: Unspecified Infection

  MAUDE report 15711947 ↗
• InjuryAug 31, 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 ON (B)(6) 2022. THE FOLLOWING IMPLANTS WERE REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP AND ELEOS TIBIAL POLY SPACER.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15332465 ↗
• InjuryNov 23, 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 WOUND INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: 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 STEM EXTENSION, TIBIAL BASEPLATE, AND CEMENTED SEGMENTAL STEM. THE SURGEON PERFORMED A WASHOUT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 12865358 ↗
• InjuryAug 4, 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 HAD FALLEN AND IT CAUSED AN OPEN SORE ON THEIR LEFT HIP. THE PATIENT LAID WITH AN OPEN WOUND FOR APPROXIMATELY TWO WEEKS. DURING THE REVISION SURGERY, THE SURGEON PERFORMED HEAVY INCISION AND DRAINAGE AND PERFORMED A BIPOLAR EXCHANGE FOR INFECTION CONTROL. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY ON (B)(6) 2020: ELEOS PROXIMAL FEMUR (98MM), ELEOS MALE-FEMALE MIDSECTION (110MM), ELEOS MALE-FEMALE MIDSECTION (70MM), AND ELEOS CEMENTED STEM (15X120MM). THE FOLLOWING IMPLANTS WERE REVISED DURING THE REVISION SURGERY: ELEOS FEMORAL HEAD (36MM, +0MM TAPER) AND A MICROPORT GLADIATOR BIPOLAR SHELL (56MM). NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 12273484 ↗
• InjuryJul 1, 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 DEVELOPED AN ALLEGED INFECTION WITH SMITH & NEPHEW IMPLANTS THAT WERE IMPLANTED ON (B)(6) 2019 FOR AN UNKNOWN REASON. THE PATIENT UNDERWENT A FIRST STAGE REVISION SURGERY ON (B)(6) 2019 WHERE THE FOLLOWING ELEOS PARTS WERE IMPLANTED: TIBIAL HINGE COMPONENT WITH ROTATIONAL STOP, TIBIAL BASEPLATE, STEM EXTENSION, DISTAL FEMUR, TIBIAL BLOCK AUGMENT, DISTAL FEMUR AXIAL PIN, SEGMENTAL STEM, AND TIBIAL POLY SPACER. THE SECOND STAGE REVISION SURGERY TOOK PLACE ON (B)(6) 2021 WHERE THE FOLLOWING ELEOS COMPONENTS WERE REMOVED AND REPLACED: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. A WASHOUT WAS PERFORMED AND ADDITIONAL ANTIBIOTICS WERE INSERTED. THE FOLLOWING ELEOS COMPONENTS ARE STILL IMPLANTED: TIBIAL BASEPLATE, STEM EXTENSION, DISTAL FEMUR, TIBIAL BLOCK AUGMENT, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12099587 ↗
• 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 8823541 ↗

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-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-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-1857-2025 · Sep 22, 2024 · Open, Classified
  ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
• 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-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-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