ELEOS™ KSC12100ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI B278KSC12100E0), received between May 14, 2020 and May 13, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO PATELLA BAJA. PATIENT'S PATELLA WAS REPORTED TO BE LOWER THAN IT SHOULD BE AND SLIGHTLY DISLOCATING. THIS REPORT CAPTURES ELEOS STEM EXTENSION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25160804 ↗
• MalfunctionSep 25, 2024Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A 57-YEAR-OLD MALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT AND ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 AFTER THE PATIENT FELL WHICH CAUSED A DISASSOCIATION OF THE STEM EXTENSION FOM THE REFURFACING FEMUR.

  Patient problems: Fall

  MAUDE report 20306091 ↗
• InjurySep 7, 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. A REVISION SURGERY HAS NOT YET BEEN SCHEDULED. THE PATIENT HAS THE FOLLOWING ELEOS DEVICES IMPLANTED: TIBIAL POLY SPACER, DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, STEM EXTENSION, THREE MALE-FEMALE MIDSECTIONS, PROXIMAL FEMUR, AND MALE-MALE MIDSECTION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17704046 ↗
• InjuryOct 23, 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 FOR A POLY SWAP OF ELEOS IMPLANTS. IT IS LIKELY THAT THE PATIENT'S IMPLANTED ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE COMPONENT, AND ELEOS POLYSPACER WERE REMOVED AND REPLACED. ON 23 SEPTEMBER 2022, ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS EVENT: IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION SURGERY, THE SURGEON REVISED THE TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S SURGERY ON (B)(6) 2022: DISTAL FEMUR, MALE-FEMALE MIDSECTION, CEMENTED SEGMENTAL STEM, CANAL-FILLING SEGMENTAL STEM, TIBIAL BASEPLATE, TWO TIBIAL BLOCK AUGMENTS, AND A CEMENTED STEM EXTENSION. ALL PARTS IMPLANTED AT THE TIME OF INFECTION WILL BE REPORTED. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION. THIS RECORD CAPTURES THE ELEOS CEMENTED STEM EXTENSION.

  Patient problems: Unspecified Infection

  MAUDE report 15656627 ↗
• InjuryMay 19, 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 19 APRIL 2022 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: ELEOS TIBIAL POLY SPACER 8MM, ELEOS RESURFACING FEMUR AXIAL PIN SIZE: 4, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS STEM EXTENSION CANAL FILLING SIZE: 14MM X 140MM STRAIGHT SPLINED SLOTTED, ELEOS TIBIAL BLOCK AUGMENT SIZE: 2 THICKNESS: 5MM, ELEOS TIBIAL BASEPLATE SIZE: 2, ELEOS STEM EXTENSION CEMENTED SIZE: 12MM X 100MM STRAIGHT FLUTED, ELEOS TIBIAL BLOCK AUGMENT SIZE: 2 THICKNESS: 5MM, AND ELEOS RESURFACING FEMUR SIZE 4 LEFT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 14439038 ↗
• InjuryMar 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 DUE TO THEIR STEM EXTENSION LOOSENING AND A FLEXION CONTRACTURE. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER, RESURFACING FEMUR, RESURFACING FEMUR AXIAL PIN, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Contracture

  MAUDE report 13675008 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10 JAN 2022, IT WAS REPORTED THAT THE PATIENT HAD AN ALLEGED FALL THAT CONTRIBUTED TO AN ALLEGED INFECTION THEY PRESENTED WITH AFTER RECEIVING TOTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2021. THE IMPLANTING SURGEON PERFORMED A DISTAL FEMUR REVISION SURGERY ON (B)(6) 2022 AND THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT W/O ROTATIONAL STOP, ELEOS TIBIAL BASEPLATE SIZE 3, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL POLY SPACER 8MM AND ELEOS DISTAL FEMUR. THE FOLLOWING IMPLANTS REMAIN IMPLANTED IN THE PATIENT: ELEOS STEM EXTENSION CEMENTED 12MM X100MM STRAIGHT FLUTED, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS MALE-FEMALE MIDSECTION 40MM, ELEOS MALE-FEMALE MIDSECTION 40MM, ELEOS PROXIMAL FEMUR 98MM LEFT 135 DEG, AND ELEOS MALE-MALE MIDSECTION 40MM. IT WAS REPORTED THAT THE SURGEON PLANS TO HAVE ONE MORE REVISION SURGERY WHEN THE INFECTION CLEARS UP. NO REVISION SURGERY HAS BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Fall; Insufficient Information; Unspecified Infection

  MAUDE report 13500640 ↗
• InjuryMay 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT UNDERWENT A REVISION SURGERY DUE TO THE RESURFACING FEMUR AND STEM EXTENSION DISSOCIATING.

  Patient problems: No Information

  MAUDE report 10059059 ↗

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-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-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-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