ELEOS™ 25002203ERecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI B27825002203E0), received between Aug 31, 2018 and Feb 9, 2022 — classified as 3 deaths, 14 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 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 13500633 ↗
• InjuryFeb 3, 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 SCHEDULED A REVISION SURGERY ON (B)(6) 2022 FOR A POLY SWAP AFTER HAVING A DISTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2021. THE REVISION SURGERY WAS CANCELLED AND HAS NOT BEEN RESCHEDULED. IT WAS CANCELLED DUE TO ALLEGED PATIENT ILLNESS. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13447637 ↗
• InjuryFeb 3, 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 FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, TIBIAL HINGE COMPONENT, CANAL-FILLING STEM, TIBIAL BASEPLATE, AND CEMENTED STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 13447164 ↗
• InjuryDec 6, 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 SURGEON REVISED THE FOLLOWING ELEOS COMPONENTS: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, CEMENTED STEM EXTENSION, CEMENTED SEGMENTAL STEM, AND TIBIAL BASEPLATE. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12933263 ↗
• InjuryNov 18, 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, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, DISTAL FEMUR, TIBIAL HINGE COMPONENT, POLY SPACER, 50MM MALE-FEMALE MIDSECTION, AND 110MM MALE-FEMALE MIDSECTION. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CEMENTED BOWED STEM, TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION. NO FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12840230 ↗
• InjuryNov 15, 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 ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, TIBIAL POLY SPACER, AND TIBIAL HINGE COMPONENT. THE SURGEON PERFORMED A WASHOUT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY: CANAL-FILLING SEGMENTAL STEM, MALE-FEMALE MIDSECTION, DISTAL FEMUR, TIBIAL BASEPLATE, (2) TIBIAL BLOCK AUGMENTS, AND CANAL-FILLING STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12816943 ↗
• 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 12576715 ↗
• InjurySep 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6). THE SURGERY WAS PERFORMED DUE TO ULCERATION AROUND ELEOS TOTAL FEMUR COMPONENT. DURING THE SURGERY, THE SURGEON REMOVED ALL IMPLANTS THAT WERE IMPLANTED AT THE TIME AS IT WAS DECIDED THAT THE PATIENT'S LEG WOULD BE AMPUTATED ABOVE THE KNEE. TO GIVE THE PATIENT'S THIGH STRUCTURE, A MALE-FEMALE MIDSECTION WITH A CUSTOM END CAP IMPLANT WAS PLACED IN THE PATIENT'S UPPER LEG.

  Patient problems: Ulcer

  MAUDE report 12441360 ↗
• InjuryApr 22, 2021Unstable; Appropriate Device Problem Term/Code Not Available

  A PATIENT UNDERWENT A SURGERY TO SURGERY TO PLACE ELEOS IMPLANTS ON 23 MARCH 2021. ELEOS IMPLANTS WERE REMOVED DURING A SURGERY ON 19 MARCH 2021 DUE TO METALOSIS AND INFECTION AS WELL AS HIP INSTABILITY.

  Patient problems: Failure of Implant

  MAUDE report 11708275 ↗
• 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 11015864 ↗
• InjuryAug 6, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 DUE TO A PERIPROSTHETIC FRACTURE OF THE ANTERIOR TIBIA AS WELL AS DISSOCIATION BETWEEN THE TIBIAL BASEPLATE AND THE TIBIAL STEM EXTENSION. THE TIBIAL BASEPLATE, STEM EXTENSION, POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN WERE EXPLANTED AND REPLACED WITH NEW IMPLANTS. THE PERIPROSTHETIC FRACTURE WAS ALSO REPAIRED DURING THE REVISION.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 10373269 ↗
• InjuryMay 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT X-RAYS REVEALED THAT THE TIBIAL BASEPLATE AND STEM EXTENSION DISSOCIATED.

  Patient problems: No Information

  MAUDE report 10059246 ↗
• InjuryJan 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE TIBIAL BASEPLATE AND STEM EXTENSION DISSOCIATING.

  Patient problems: No Information

  MAUDE report 9633787 ↗
• 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 8823557 ↗
• 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 8823550 ↗
• InjuryDec 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT X-RAYS REVEALED THAT THE TIBIAL STEM SUBSIDED WITHIN THE INTRAMEDULLARY CANAL AND THAT THE TIBIAL STEM AND TIBIAL BASEPLATE DISSOCIATED, WHICH REQUIRED SURGICAL INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 8164769 ↗
• 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 7839686 ↗

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-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-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-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
• 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