ELEOS™ 25002112ERecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI B27825002112E0), received between Jun 11, 2019 and May 13, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 22 most recent of 22 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 AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25160807 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS HINGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23981837 ↗
• 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 HINGE KNEE REPLACEMENT WAS REPORTEDLY DUE TO REVISION DUE TO AN ALLEGED INFECTION; HOWEVER, THERE IS NO INDICATION THAT THE REVISION SURGERY TOOK PLACE AND NO EVIDENCE THAT ONKOS DEVICES WERE REVISED. IT WAS LATER REPORTED THAT THE PATIENT HAD AN ABNORMAL GROWTH UNRELATED TO AN ONKOS ELEOS IMPLANT THAT REQUIRED REMOVAL. A SUPPLEMENTAL MDR WILL BE SUBMITTED TO CLARIFY THAT THERE WAS NO REPORTED FAILURE OF ONKOS DEVICES. THIS MDR CAPTURES THE REVIEW OF ELEOS AXIAL PIN.

  Patient problems: Unspecified Infection

  MAUDE report 23583518 ↗
• InjurySep 12, 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 71-YEAR-OLD FEMALE PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. WASHOUT AND SWAPPED COMPONENTS. THIS REPORT CAPTURES THE ELEOS AXIAL PIN. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23037398 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HISTORICAL REVISION FOR A 71-YEAR-OLD FEMALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT OCCURRED ON (B)(6) 2024. THIS REVISION WAS DISCOVERED DURING THE INVESTIGATION OF A SUBSEQUENT REVISION DUE TO INFECTION WHICH WAS INVESTIGATED VIA (B)(4).

  Patient problems: Medical device site infection

  MAUDE report 21036444 ↗
• InjuryDec 30, 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 71-YEAR-OLD FEMALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21036098 ↗
• InjuryJun 20, 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 FEMALE PATIENT WITH AN ELEOS HINGE KNEE REPLACEMENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 19577038 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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, RESURFACING FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: STEM EXTENSION, SEGMENTAL STEM, RESURFACING FEMUR, AND PROXIMAL TIBIA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 17566119 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH ONKOS DEVICES ON (B)(6) 2022. AN ONKOS CUSTOM ADAPTOR WAS CREATED TO CONNECT TO THE PATIENT'S PREVIOUSLY EXISTING HARDWARE TO THE ONKOS DISTAL FEMUR REPLACEMENT SYSTEM. IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2022 DUE TO AN INFECTION. THE FOLLOWING IMPLANTED DEVICES WERE REMOVED DURING THE REVISION PROCEDURE: CUSTOM COMPRESS ADAPTOR, ELEOS TIBIAL HINGE, ELEOS TIBIAL POLY SPACER, ELEOS TIBIAL BASEPLATE, ELEOS TIBIAL BASEPLATE TAPERED SCREW, TWO ELEOS MALE-FEMALE MIDSECTIONS, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR, AND AN ELEOS TIBIAL BASEPLATE. THIS RECORD CAPTURES THE ELEOS DISTAL FEMUR AXIAL PIN. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 14649419 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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 13675203 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2022 FOR AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE EXPLANTED: ELEOS PROXIMAL TIBIA 87MM, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS TIBIAL POLY SPACER 8MM, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE IMPLANTED: ELEOS PROXIMAL TIBIA 87MM, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS TIBIAL POLY SPACER 8MM, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS RESURFACING FEMUR AXIAL PIN SIZE 2. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13586322 ↗
• InjuryJan 20, 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) 2021 DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, DR. (B)(6) REVISED THE TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND RESURFACING FEMUR AXIAL PIN. DR. (B)(6) PERFORMED A WASHOUT. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY ON (B)(6) 2021: RESURFACING FEMUR, CANAL-FILLING STEM EXTENSION (18X140MM), TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION (18X100MM). NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13307223 ↗
• InjuryNov 6, 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. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: RESURFACING FEMUR AXIAL PIN, POLY SPACER, AND TIBIAL HINGE COMPONENT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY: CEMENTED STEM EXTENSION, BIOGRIP COLLAR, COLLAR LOCKING RING, RESURFACING FEMUR, CEMENTED STEM, AND PROXIMAL TIBIA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12755822 ↗
• 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 12349945 ↗
• 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 12349198 ↗
• InjuryJun 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 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 (16MM X 140MM), CANAL-FILLING STEM EXTENSION (14MM X 100MM), TIBIAL BASEPLATE. 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 12016785 ↗
• InjuryMar 12, 2021Adverse 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 11478380 ↗
• InjuryOct 13, 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 10672436 ↗
• InjuryMar 25, 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. THE SALES REPRESENTATIVE, PRESENT DURING THE SURGERY, RELAYED THAT UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE FEMORAL AND TIBIAL IMPLANTS HAD LOOSENED.

  Patient problems: Unspecified Infection

  MAUDE report 9878855 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9745001 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION.

  Patient problems: Joint Swelling; Unspecified Infection

  MAUDE report 9356971 ↗
• MalfunctionJun 11, 2019Device Damaged by Another Device; Device Damaged by Another Device

  AN ELEOS RESURFACING FEMUR LIMB SALVAGE SYSTEM WAS IMPLANTED AND WHILE ASSEMBLING THE COMPONENTS, THE THREADS OF THE AXIAL PIN INSERTER/EXTRACTOR FRACTURED OFF WITHIN THE RESURFACING FEMUR AXIAL PIN. THE RESURFACING FEMUR AXIAL PIN WAS REMOVED, AND A NEW PIN WAS PLACED.

  Patient problems: No Information

  MAUDE report 8688677 ↗

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-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-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