ELEOS™ KSC18100ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI B278KSC18100E0), received between Jun 8, 2018 and Jul 25, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AND ONKOS SALES REPRESENTATIVE, THAT A 78-YEAR-OLD FEMALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO LOOSENING OF THE FEMORAL STEM EXTENSION. THE SALES REPRESENTATIVE REPORTED THAT THE PATIENT RESULTED IN BONE FRACTURE UPON EXPLANTATION. THIS REPORT CAPTURES THE ELEOS STEM EXTENSION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening; Periprosthetic fracture

  MAUDE report 22610759 ↗
• 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 STRAIGHT CEMENTED STEM. ON 17 MARCH 2023 UPDATE: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS DETERMINED THAT THE PATIENT'S ELEOS STEM EXTENSION HAD DISASSOCIATED FROM THE ELEOS RESURFACING FEMUR, NOT

  Patient problems: Insufficient Information

  MAUDE report 16038545 ↗
• 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 STEM EXTENSION.

  Patient problems: Unspecified Infection

  MAUDE report 15711908 ↗
• InjuryFeb 19, 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 IMPLANTS: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER, AND GUARDIAN RESURFACING FEMUR AXIAL PIN. THE SURGEON PERFORMED A WASHOUT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: TIBIAL BASEPLATE, CEMENTED STEM EXTENSION (18X100MM), CEMENTED STEM EXTENSION (16X65MM), RESURFACING FEMUR, TIBIAL BASEPLATE TAPERED SCREW, AND RESURFACING FEMUR TAPERED SCREW. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS NOT BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13565393 ↗
• InjuryAug 30, 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 FOLLOWING PARTS WERE REMOVED AND REVISED: RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: 2 TIBIAL BLOCK AUGMENTS, RESURFACING FEMUR, CEMENTED STEM EXTENSION (18MM X 100MM), CEMENTED STEM EXTENSION (16MM X 65MM), AND TIBIAL BASEPLATE. THE SURGEON PERFORMED A WASHOUT AND ADMINISTERED ANTIBIOTICS. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12385874 ↗
• MalfunctionOct 5, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2020, A (B)(6)-YEAR-OLD FEMALE UNDERWENT A REVISION SURGERY DUE TO DISSOCIATION OF STEM EXTENSION AND RESURFACING FEMUR DISSOCIATED. DURING THE REVISION SURGERY, THE TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER, RESURFACING FEMUR, AND RESURFACING FEMUR AXIAL PIN WERE ALL REPLACED WITH IDENTICAL IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 10631451 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STEM PERFORATED THE FEMORAL ANTERIOR CORTEX, WHILE BEING IMPLANTED. A REVISION SURGERY WAS SCHEDULED TO REVISE THE HINGE KNEE TO A DISTAL FEMUR SYSTEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 9813792 ↗
• InjuryJun 8, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED ON ELEOS RESURFACING HINGE KNEE WHERE IT APPEARED ON X-RAYS THAT THE RESURFACING FEMUR AND STEM EXTENSION HAD DISSOCIATED. UPON REMOVAL OF THE COMPONENTS IT WAS DISCOVERED THAT THE RESURFACING FEMUR HAD ALSO LOOSENED.

  Patient problems: Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 7582361 ↗

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