ELEOS™ KSC16100ERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI B278KSC16100E0), received between Mar 13, 2018 and Jun 12, 2024 — classified as 2 deaths, 8 injuries.

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

• InjuryJun 12, 2024Unstable; Unstable

  IT WAS REPORTED BY (B)(6) , AN ONKOS SALES REPRESENTATIVE, THAT A 61-YEAR-OLD MALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE FEMORAL STEM. THE PATIENT WAS CONVERTED TO AN ELEOS DISTAL FEMUR REPLACEMENT DURING THE OPERATION WHICH WAS PERFORMED BY DOCTOR (B)(6) ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19524113 ↗
• InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND OPENED THEIR INCISION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE SURGEON PERFORMED INCISION AND DRAINAGE AND REVISED THE FOLLOWING IMPLANTS: POLY SPACER, DISTAL FEMUR AXIAL PIN, AND TIBIAL HINGE COMPONENT. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, TIBIAL BASEPLATE, CEMENTED STEM EXTENSION, AND CANAL-FILLING SEGMENTAL STEM. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 15307887 ↗
• InjuryFeb 3, 2022Adverse 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) 2022 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, TIBIAL HINGE COMPONENT, CANAL-FILLING STEM, TIBIAL BASEPLATE, AND CEMENTED STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 13447163 ↗
• InjuryJul 13, 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 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 ORGIINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: RESURFACING FEMUR, CEMENTED STEM EXTENSION, CEMENTED SEGMENTAL STEM, PROXIMAL TIBIA, AND MALE-FEMALE MIDSECTION. THE SURGEON REMOVED IMPLANTS WITH POLY COMPONENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12164249 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT AN AMPUTATION SURGERY PERFORMED BY DR. BOWLING ON (B)(6) 2020 DUE TO AN ALLEGED INFECTION OF ELEOS COMPONENTS. INSTEAD OF REVISION, THE PATIENT OPTED FOR AMPUTATION OF THE LIMB ABOVE THE KNEE. THE PATIENT UNDERWENT HIS PRIMARY ELEOS SURGERY ON (B)(6) 2019 WHERE HE UNDERWENT A REVISION OF A TOTAL KNEE ARTHROPLASTY. THE FOLLOWING IMPLANTS WERE PLACED DURING THE PRIMARY ELEOS SURGERY, AND WERE REMOVED DURING THE AMPUTATION SURGERY: A TIBIAL BASEPLATE, TWO TIBIAL BLOCK AUGMENTS, TWO CEMENTED STEM EXTENSIONS, A RESURFACING FEMUR, A RESURFACING FEMUR AXIAL PIN, A TIBIAL HINGE COMPONENT, AND A TIBIAL POLY SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 11015947 ↗
• DeathJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DIED DUE TO AN ALLEGED INFECTION.

  Patient problems: Death

  MAUDE report 10150643 ↗
• InjuryJun 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT UNDERWENT A REVISION SURGERY DUE TO A DEEP LATE INFECTION. UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE RESURFACING FEMUR AND STEM EXTENSION DISSOCIATED.

  Patient problems: Unspecified Infection

  MAUDE report 10123809 ↗
• InjuryDec 14, 2018Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  PATIENT X-RAYS REVEALED THAT THE TIBIAL STEM SUBSIDED WITHIN THE INTRAMEDULLARY CANAL AND THAT THE TIBIAL STEM AND TIBIAL BASEPLATE DISSOCIATED, WHICH REQUIRED SURGICAL INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 8164776 ↗
• DeathAug 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WENT INTO CARDIAC ARREST, DURING A REVISION SURGERY, AND WAS UNABLE TO BE RESUSCITATED. THE REVISION SURGERY WAS PERFORMED TO REMOVE UNKNOWN COMPONENTS DUE TO A COMMINUTED SUPRACONDYLAR FRACTURE ON THEIR DISTAL FEMUR AND PLACE AN ELEOS DISTAL FEMUR LIMB SALVAGE SYSTEM.

  Patient problems: Sudden Cardiac Death

  MAUDE report 7839725 ↗
• InjuryMar 13, 2018Detachment of Device or Device Component; Detachment Of Device Component; Fracture; Loose or Intermittent Connection; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED ON ELEOS RESURFACING HINGE KNEE WHERE IT APPEARED ON X-RAYS THAT THE FEMORAL COMPONENT HAD DISSOCIATED FROM THE STEM EXTENSION. UPON REMOVAL OF THE COMPONENTS IT WAS DISCOVERED THAT THE RESURFACING FEMUR HAD LOOSENED AND THE WALL OF THE FEMALE BOSS HAD FRACTURED ON ONE SIDE.

  Patient problems: Fall; No Information

  MAUDE report 7334931 ↗

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-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-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
• 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