ELEOS™ 25002201ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI B27825002201E0), received between Mar 25, 2020 and Oct 11, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS IDENTIFIED ON (B)(6) 2023 THAT A PATIENT UNDERWENT A REVISION PROCEDURE IN 2017. THE PATIENT WAS EXPERIENCING PATELLA BAJA IN THE LEFT KNEE JOINT. IN THIS CASE, ELEOS COMPONENTS WERE REPLACED WITH NON-ONKOS DEVICES.ON (B)(6) 2023, THROUGH INVESTIGATION OF MDR 3013450937-2023-00122 , ADDITIONAL INFORMATION WAS RECEIVED REGARDING COMPONENTS WHICH WERE REVISED.- AN ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER, AND ELEOS TIBIAL BASEPLATE WAS REVISED. THIS RECORD CAPTURES THE ELEOS TIBIAL BASEPLATE MDR 3013450937-2023-00122 CAPTURES THE ELEOS TIBIAL HINGE COMPONENT. MDR 3013450937-2023-00205 CAPTURES THE ELEOS TIBIAL POLY SPACER.

  Patient problems: Joint Laxity; Limb Pain

  MAUDE report 17917360 ↗
• 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 13307224 ↗
• 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 12016802 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY, THE SURGEON EXPLANTED THE FOLLOWING COMPONENTS: A TIBIAL HINGE COMPONENT, A TIBIAL POLY SPACER, AND A DISTAL FEMUR AXIAL PIN. THE FOLLOWING IMPLANTS WERE ALSO IMPLANTED IN THE PATIENT AT THE TIME OF THE INFECTION AND REVISION SURGERY: A SEGMENTAL STEM, A TIBIAL BASEPLATE, A DISTAL FEMUR COMPONENT, AND A STEM EXTENSION. THE SURGEON PERFORMED A WASHOUT OF THE AREA AND REVISED ALL OF THE IMPLANTS THAT CONTAINED POLY COMPONENTS. NO FUTHER INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED.

  Patient problems: Unspecified Infection

  MAUDE report 11966889 ↗
• InjurySep 9, 2020Connection Problem; Connection Problem

  A (B)(6)-YEAR-OLD MALE UNDERWENT A REVISION SURGERY OF ELEOS COMPONENTS ON (B)(6) 2020 PERFORMED BY DR. (B)(6) DUE TO THE PATIENT'S TIBIAL HINGE COMPONENT DISLOCATING CAUSING THE LOWER LEG TO SEPARATE FROM THE UPPER LEG. THE TIBIAL AUGMENT THAT WAS PLACED DURING THE PRIMARY SURGERY BUT WAS REMOVED DURING THE REVISION SURGERY AND NOT REPLACED. A 20MM POLY SPACER WAS REMOVED AND REPLACED WITH AN 8MM POLY SPACER. BONE WAS RESECTED FROM THE TIBIA AND A 40MM MIDSECTION WAS PLACED. A 16MM X 100MM STEM EXTENSION WAS REMOVED AND REPLACED WITH A 15MM X 100MM STEM EXTENSION. THE REASON FOR THE SIZE CHANGE OF THE STEM EXTENSION IS NOT KNOWN. THE SEGMENTAL STEM THAT WAS PLACED DURING THE PRIMARY SURGERY WAS NOT EXPLANTED DURING THE REVISION. THE SURGEON EXPECTED THE IMPLANT DURING SURGERY AND STATED THAT IT WAS NOT DAMAGED. A DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL BASEPLATE, AND DISTAL FEMUR COMPONENTS WERE EXPLANTED AND REPLACED WITH IDENTICAL COMPONENTS.

  Patient problems: Joint Dislocation

  MAUDE report 10510291 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT THEIR FEMUR, TIBIA, AND FIBULA FRACTURED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10009604 ↗
• InjuryMar 25, 2020Loss of Osseointegration; Loss of Osseointegration

  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 9878856 ↗

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-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-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