ELEOS™ 25001216ERecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI B27825001216E0), received between Aug 8, 2018 and May 27, 2026 — classified as 1 death, 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. PATIENT UNDERWENT A BILATERAL REVISION SURGERY. THIS REPORT CAPTURES ELEOS POLY SPACER (RIGHT). THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25302913 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. PATIENT UNDERWENT A BILATERAL REVISION SURGERY. THIS REPORT CAPTURES ELEOS POLY SPACER (LEFT). THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25302908 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS HIMGE KNEE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 24701171 ↗
• InjuryDec 15, 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 AN ALLEGED INFECTION. IT WAS REPORTED THAT THE PATIENT IS OVER 600 LBS. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23811241 ↗
• InjuryNov 24, 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 AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23630852 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ONKOS SALES REPRESENTATIVE REPORTED THAT A PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 22137111 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ONKOS SALES REPRESENTATIVE REPORTED A REVISION SURGERY WHICH TOOK PLACE ON (B)(6) 2025 DUE TO AN ALLEGED PERIPROSTHETIC JOINT INFECTION IN AN 85-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT.

  Patient problems: Medical device site infection

  MAUDE report 21979056 ↗
• InjuryMar 18, 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 73-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21635415 ↗
• InjuryFeb 6, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN ONKOS ELEOS PROXIMAL TIBIAL REPLACEMENT, EXPERIENCED DISLOCATION OF THE ELEOS POLY SPACER AND ELEOS TIBIAL HINGE COMPONENT. THE PATIENT WILL UNDERGO A REVISION PROCEDURE AT AN UNKNOWN DATE TO ADDRESS THE DISLOCATION. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY DUE TO THE SCHEDULED REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327374 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY T. STAMPER, AN ONKOS SALES REPRESENTATIVE, THAT A 61-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024.

  Patient problems: Medical device site infection

  MAUDE report 21038369 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4), AN ONKOS DISTRIBUTOR, THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS AN ALLEGED INFECTION. THE SURGERY TOOK PLACE ON (B)(6) 2024 AND IS THE SECOND REVISION SURGERY FOR THIS PATIENT IN WHICH ELEOS DEVICES WERE REVISED. AT THE TIME OF THIS REVISION SURGERY, THE THEN 55-YEAR-OLD FEMALE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT HAD NINE (9) ELEOS COMPONENTS EXPLANTED AND REPLACED EXCEPT FOR THE FEMORAL HEAD WHICH WAS REPLACED WITH A NON-ONKOS DEVICE.

  Patient problems: Medical device site infection

  MAUDE report 18989331 ↗
• InjuryJan 5, 2024Adverse 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 AN ONKOS RESURFACING HINGE ORIGINALLY IMPLANTED. THE PATIENTS PATELLA STARTED SUBLUXING. SURGEONS PERFORMED A PETELLAECTOMY AND EXTENSOR MECHANISM AND DID FRESH POLY EXCHANGE WHILE AT IT.

  Patient problems: Damage to Ligament(s); Subluxation

  MAUDE report 18452007 ↗
• InjurySep 22, 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: TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER, AND RESURFACING FEMUR AXIAL PIN. THE DATE OF THIS PATIENT'S ORIGINAL SURGERY IS UNKNOWN, THEREFORE, IT IS NOT KNOWN IF THERE ARE OTHER IMPLANTS PLACED AT THE TIME OF THIS ALLEGED INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 17801467 ↗
• InjuryMay 1, 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. THE 16MM POLY SPACER WAS REVISED TO A 20MM POLY SPACER. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 16843961 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY. THE FOLLOWING IMPLANTS WERE REMOVED AND REPLACED DURING THE REVISION: ELEOS TIBIAL HINGE, ELEOS TIBIAL POLY SPACER AND ELEOS DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 14988744 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S MARGINS IN SOFT TISSUE WERE NOT CLEAR WHEN PATHOLOGY CAME BACK POST-OP AND THEREFORE A REVISION SURGERY WAS PERFORMED TO EXTEND THE RESECTION OF SOFT TISSUE AND REPLACE EASILY REPLACEABLE COMPONENTS. DURING THE REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS RESURFACING FEMUR AXIAL PIN SIZE 3, ELEOS TIBIAL HINGE WITH ROTATIONAL STOP, AND ELEOS TIBIAL POLY SPACER 16MM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13261709 ↗
• MalfunctionOct 5, 2020Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 PERFORMED BY DR. (B)(6) DUE TO AN ALLEGED INFECTION. THE SURGEON PERFORMED AN INCISION AND DRAINAGE PROCEDURE TO REMOVE THE INFECTED TISSUE. THE TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND THE DISTAL FEMUR AXIAL PIN WERE ALL REVISED WITH IDENTICAL IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 10632318 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS UNABLE TO GET FULL EXTENSION OF THEIR LEG AND SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Code Available

  MAUDE report 10119363 ↗
• InjuryJan 13, 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 ACUTE ON CHRONIC SEPTIC ARTHRITIS TOTAL KNEE ARTHROPLASTY.

  Patient problems: Unspecified Infection

  MAUDE report 9582279 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: No Information; Unspecified Infection

  MAUDE report 9503721 ↗
• InjurySep 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO INSTABILITY, CHRONIC SUBLUXATION OF THE PATELLA, AND SEVERE ARTHROFIBROSIS.

  Patient problems: Arthritis

  MAUDE report 7868845 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH A LUMP ON THEIR KNEE, WHICH WAS SUSPECTED TO BE CAUSED BY AN INFECTION. A REVISION SURGERY WAS PERFORMED TO DRAIN AND IRRIGATE THE KNEE. UPON REMOVING THE POLY COMPONENTS, THE SURGEON OBSERVED THAT THE CEMENTED STEM WAS LOOSE. THE SURGEON WASHED THE FEMORAL INTRAMEDULLARY CANAL AND PLACED NEW COMPONENTS WITHOUT CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 7855626 ↗
• 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 7839678 ↗
• InjuryAug 30, 2018Adverse 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 7835024 ↗
• InjuryAug 29, 2018Adverse 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 7828562 ↗

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-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-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-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