ELEOS™ KSC01530ERecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI B278KSC01530E0), received between Jul 24, 2019 and Sep 30, 2024 — classified as 3 deaths, 14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH AN ONKOS DISTAL FEMORAL REPLACEMENT HAD AN ALLEGED INFECTION. THE PATIENT'S INDEX PROCEDURE OCCURED ON (B)(6) 2024. THE PATIENT UNDERWENT A PROCEDURE TO REMOVE ALL HARDWARE AND ELECTED TO UNDERGO AN AMPUTATION ON (B)(6) 2024. THIS EVENT WILL BE REPORTABLE TO THE FDA DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES THE EXPLANTED ELEOS STEM EXTENSION.

  Patient problems: Unspecified Infection

  MAUDE report 20338744 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY S. STEINERT, AN ONKOS SALES REPRESENTATIVE, THAT A 74-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO A DISLOCATION OF THE TIBIAL HINGE AND TIBIAL POLY SPACER FROM THE TIBIAL BASEPLATE. ACCORDING TO (B)(6), THE SURGEON, DOCTOR (B)(6), BELIEVED THE PATIENT TO BE NON-COMPLAINT POST-SURGERY WHICH MAY HAVE CONTRIBUTED TO THE PATIENT FALLING.

  Patient problems: Joint Dislocation

  MAUDE report 19671318 ↗
• InjuryAug 16, 2023Adverse 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. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: DISTAL FEMUR, MALE-FEMALE MIDSECTION, STEM EXTENSION, RESURFACING PATELLA, TIBIAL BASEPLATE, CEMENTED BOWED SEGMENTAL STEM, AND TIBIAL BASEPLATE TAPERED SCREW. THE SURGEON PERFORMED A WASHOUT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17560957 ↗
• InjuryJul 20, 2023Adverse 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 PATELLA BAJA AND FLEXION CONTRACTURE. DURING THE REVISION SURGERY, THE SURGEON IDENTIFIED THAT THE PATIENT HAD DEVELOPED BONE OSTEOPHYTES AND SCAR TISSUE FORMATION. THE SURGEON REMOVED AS MUCH SCAR TISSUE AND BONE OSTEOPHYTES AS POSSIBLE. THE SURGEON REVISED THE DISTAL FEMUR, DISTAL FEMUR AXIAL PIN, TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND MALE-FEMALE MIDSECTION. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: BIOGRIP HA COLLAR, COLLAR LOCKING RING, SEGMENTAL STEM, TIBIAL BASEPLATE, TIBIAL BASEPLATE TAPERED SCREW, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Scar Tissue

  MAUDE report 17364558 ↗
• InjuryMay 9, 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 EXPLANTED: TWO CEMENTED STEM EXTENSIONS, TIBIAL HINGE COMPONENT, RESURFACING FEMUR AXIAL PIN, POLY SPACER, TIBIAL BASEPLATE, TIBIAL BASEPLATE TAPERED SCREW, RESURFACING FEMUR, AND RESURFACING FEMUR TAPERED SCREW. THE SURGEON PLACED AN ANTIBIOTIC SPACER. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16899522 ↗
• InjuryMar 24, 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 16616289 ↗
• InjuryNov 23, 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 SURGEON REVISED THE FOLLOWING ELEOS IMPLANTS: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, DISTAL FEMUR, BIOGRIP COLLAR, COLLAR LOCKING RING, CEMENTED STEM EXTENSION, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15855385 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND DEVELOPED AN ALLEGED INFECTION AND HEMATOMAS. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, TIBIAL BASEPLATE, AND CEMENTED STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Hematoma; Pain; Unspecified Infection

  MAUDE report 15477989 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2022 DUE TO AN ALLEGED INFECTION. THE PATIENT UNDERWENT A POLYSWAP PROCEDURE. THE FOLLOWING IMPLANTS WERE REVISED: ELEOS DISTAL FEMUR, AXIAL PIN, TIBIAL HINGE COMPONENT, SEGMENTAL STEM - CEMENTED, MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, TWO TIBIAL AUGMENTS, STEM EXTENSION - CEMENTED, AND A POLY SPACER. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY DUE TO REVISION SURGERY. THIS RECORD CAPTURES THE ELEOS CEMENTED STEM EXTENSION.

  Patient problems: Unspecified Infection

  MAUDE report 14120786 ↗
• 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 12712503 ↗
• InjuryOct 5, 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. DURING THE REVISION SURGERY, THE FOLLOWING IMPLANTS WERE REVISED: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR, ELEOS TIBIAL POLY SPACER, ELEOS SEGMENTAL STEM, AND ELEOS TIBIAL HINGE COMPONENT. ADDITIONAL INFORMATION WAS RECEIVED THAT IDENTIFIED THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL ELEOS SURGERY: TIBIAL BASEPLATE, 2 TIBIAL BLOCK AUGMENTS, STEM EXTENSION, AND MODULAR TIBIAL BASE STEM CAP. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS NOT BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12576705 ↗
• InjurySep 23, 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 PART WERE REMOVED AND REVISED: DISTAL 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: TIBIAL BASEPLATE, DISTAL FEMUR, STEM EXTENSION, COLLAR, COLLAR LOCKING RING, AND CEMENTED STEM . THE SURGEON REMOVED IMPLANTS WITH POLY COMOPENTS AND PERFORMED INCISION AND DRAINAGE. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12523213 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT AN AMPUTATION SURGERY PERFORMED BY DR. (B)(6) 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 11015804 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10280032 ↗
• 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 10150641 ↗
• 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 8823553 ↗
• 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 8823547 ↗

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-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-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-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
• 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