ELEOS™ 25001220ERecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI B27825001220E0), received between Aug 8, 2018 and Nov 18, 2025 — classified as 30 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 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 A LONG-TERM PAIN. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Limb Pain

  MAUDE report 23585516 ↗
• InjuryOct 23, 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 A DISLOCATION OF THE TIBIAL POLY SPACER AND ROTATIONAL HINGE FROM THE TIBIAL BASEPLATE. THE PATIENT REPORTEDLY JUMPED THE POST WHICH LED TO THE DISLOCATION. THIS REPORT CAPTURES THE ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 23375999 ↗
• InjuryJul 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN ONKOS ELEOS DISTAL FEMUR REPLACEMENT, EXPERIENCED DISLOCATION OF THE ELEOS POLY SPACER AND ELEOS TIBIAL HINGE COMPONENT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES THE ELEOS POLY SPACER.

  Patient problems: Insufficient Information

  MAUDE report 22391262 ↗
• InjuryJul 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN ELEOS DISTAL FEMORAL REPLACEMENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION OF THEIR ELEOS POLY SPACER. THE PATIENT WAS REVISED ON (B)(6) 2025. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22390360 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AN ONKOS SALES REPRESENTATIVE, THAT A 81-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21235910 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HISTORICAL ADVERSE EVENT WAS DISCOVERED DURING THE INVESTIGATION OF PCR 12032024-4, WHEREIN A 68-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 21029225 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY D. HARDARDT, AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO A DISLOCATION OF THE TIBIAL POLY SPACER AND ROTATIONAL HINGE FROM THE TIBIAL BASEPLATE. THE PATIENT REPORTEDLY JUMPED THE POST WHICH LED TO THE DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 21021474 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY P. MEDINA, AN ONKOS SALES REPRESENTATIVE, THAT A 56-YEAR-OLD MALE PATIENT WITH AN ELEOS TOTAL FEMUR & PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO A DISLOCATION OF THE TIBIAL POLY SPACER AND TIBIAL ROTATIONAL HINGE FROM THE PROXIMAL TIBIA. THE PATIENT REPORTEDLY JUMPED THE POST WHICH LED TO THE DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 20615819 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6) AN ONKOS SALES REPRESENTATIVE, THAT A 52-YEAR-OLD MALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY DUE TO A DISLOCATION OF THE TIBIAL HINGE AND TIBIAL POLY SPACER FROM THE TIBIAL BASEPLATE. THE REVISION WAS PERFORMED BY DOCTOR (B)(6) ON (B)(6) 2024.

  Patient problems: Joint Dislocation

  MAUDE report 19833415 ↗
• 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 19671363 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), 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 19610056 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4), AN ONKOS SALES REPRESENTATIVE, THAT A 77-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE SURGEON, DOCTOR (B)(4), WASHED OUT THE OPERATIVE JOINT AND REPLACED THE ELEOS DEVICES LISTED ABOVE.

  Patient problems: Medical device site infection

  MAUDE report 19373833 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT FELL AND DISLOCATED. DR. (B)(6) WENT IN RELOCATED THE PROSTHESIS AND REPLACED THE POLY, AXIAL PIN AND TIBIAL HINGE COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 18322646 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT FELL AND DISLOCATED. DR. (B)(6) WENT IN RELOCATED THE PROSTHESIS AND REPLACED THE POLY, AXIAL PIN AND TIBIAL HINGE COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 18322645 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT FELL AND DISLOCATED. DR. (B)(6) WENT IN RELOCATED THE PROSTHESIS AND REPLACED THE POLY, AXIAL PIN AND TIBIAL HINGE COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 18322644 ↗
• InjurySep 15, 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 ON (B)(6) 2023 DUE TO PATELLA PAIN. DURING THE REVISION SURGERY, THE SURGEON REVISED THE DISTAL FEMUR AXIAL PIN, POLY SPACER, AND NON-ONKOS TIBIAL HINGE COMPONENT. THE SURGEON WANTED TO LOWER THE PATIENT'S JOINT LINE, THEREFORE, THEY REVISED THE 20MM TIBIAL POLY SPACER TO AN 8MM TIBIAL POLY SPACER. THERE WERE NO ALLEGED MALFUNCTIONS OF THE DISTAL FEMUR AXIAL PIN AND NON-ONKOS TIBIAL HINGE COMPONENT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 17760700 ↗
• InjuryAug 22, 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 ON (B)(6) 2023 DUE TO SOFT TISSUE LAXITY. DURING THE REVISION SURGERY, THE SURGEON REVISED THE DISTAL FEMUR AXIAL PIN, POLY SPACER, AND TIBIAL HINGE COMPONENT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 17594882 ↗
• InjuryJul 27, 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. ADDITIONAL INFORMATION IS NOT KNOWN AT THIS TIME. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION. THIS RECORD CAPTURES THE ELEOS POLY SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 15116831 ↗
• InjuryJan 14, 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) 2020 DUE TO AN ALLEGED INFECTION. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS WERE IMPLANTED AT THE TIME AND WERE NOT REVISED DURING THIS REVISION SURGERY: SEGMENTAL STEM, STEM EXTENSION, TIBIAL BASEPLATE AND CEMENTED STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13261663 ↗
• InjuryDec 29, 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 INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, ALL OF THE ELEOS IMPLANTS WERE EXPLANTED AND A STRYKER INTERCALARY SYSTEM WAS PLACED. THE FOLLOWING ELEOS IMPLANTS WERE EXPLANTED ON (B)(6) 2021: PROXIMAL TIBIA, POLY SPACER, TIBIAL HINGE COMPONENT, CANAL-FILLING STEM EXTENSION, RESURFACING FEMUR AXIAL PIN, SEGMENTAL STEM, RESURFACING FEMUR, AND RESURFACING PATELLA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13115764 ↗
• InjuryDec 17, 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 AND A LOOSE CEMENTED SEGMENTAL STEM. THE SURGEON PERFORMED INCISION & DRAINAGE. THE FOLLOWING ELEOS IMPLANTS WERE REVISED: POLY SPACER, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, DISTAL FEMUR, AND CEMENTED SEGMENTAL STEM. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: TIBIAL BASEPLATE AND CEMENTED STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13029759 ↗
• InjuryAug 20, 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 ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: RESURFACING FEMUR, CANAL-FILLING STEM EXTENSION (23MM X 100MM). THE SURGEON REMOVED AND REVISED THE IMPLANTS WITH POLY COMPONENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12349930 ↗
• InjuryAug 20, 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 ORIGINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: RESURFACING FEMUR, CANAL-FILLING STEM EXTENSION (23MM X 100MM). THE SURGEON REMOVED AND REVISED THE IMPLANTS WITH POLY COMPONENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12349199 ↗
• InjuryNov 19, 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 10870055 ↗
• InjurySep 11, 2020Loose or Intermittent Connection; Insufficient Device Problem Information; Loose or Intermittent Connection

  A (B)(6) FEMALE UNDERWENT A REVISION SURGERY ON (B)(6) 2020 PERFORMED BY DR.(B)(6). THE DETAILS OF THE EVENT ARE UNKNOWN AT THIS TIME. THE SALES REPRESENTATIVE HAS NOT RESPONDED TO INQUIRIES REGARDING THIS INCIDENT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN MORE INFORMATION IS KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 10525124 ↗

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-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-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-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-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-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
• 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