ELEOS™ 25002202ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI B27825002202E0), received between Oct 30, 2020 and May 19, 2022 — classified as 11 injuries.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 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 19 APRIL 2022 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: ELEOS TIBIAL POLY SPACER 8MM, ELEOS RESURFACING FEMUR AXIAL PIN SIZE: 4, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS STEM EXTENSION CANAL FILLING SIZE: 14MM X 140MM STRAIGHT SPLINED SLOTTED, ELEOS TIBIAL BLOCK AUGMENT SIZE: 2 THICKNESS: 5MM, ELEOS TIBIAL BASEPLATE SIZE: 2, ELEOS STEM EXTENSION CEMENTED SIZE: 12MM X 100MM STRAIGHT FLUTED, ELEOS TIBIAL BLOCK AUGMENT SIZE: 2 THICKNESS: 5MM, AND ELEOS RESURFACING FEMUR SIZE 4 LEFT. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 14438799 ↗
• InjuryFeb 13, 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. THE PATIENT GOT INTO A CAR ACCIDENT WHICH OPENED THEIR INCISION AND IT BECAME INFECTED. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR, MALE-FEMALE MIDSECTION, POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S PREVIOUS SURGERIES: CEMENTED SEGMENTAL STEM, CANAL-FILLING STEM EXTENSION, AND TIBIAL BASEPLATE. THE SURGEON USED ANTIBIOTIC CEMENT. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection; Wound Infection

  MAUDE report 13519384 ↗
• InjuryFeb 12, 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 TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS TIBIAL POLY SPACER 8MM, ELEOS SEGMENTAL STEM CEMENTED 13MM X 152MM STRAIGHT FLUTED 25MM COLLAR, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS DISTAL FEMUR RIGHT SEGMENTAL, AND ELEOS DISTAL FEMUR AXIAL PIN. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE IMPLANTED: ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS TIBIAL POLY SPACER 8MM, A MICROPORT STEM AND A CEMENT SPACER. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS TIBIAL BASEPLATE SIZE 2 AND ELEOS STEM EXTENSION CANAL FILLING 12MM X 100MM STRAIGHT SPLINED SLOTTED. IT WAS REPORTED THAT THE SURGEON PLANS TO HAVE ANOTHER REVISION SURGERY. NO REVISION SURGERY HAS BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13519273 ↗
• 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 13261668 ↗
• 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 13029786 ↗
• InjuryNov 4, 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 FOLLOWING ELEOS IMPLANTS WERE REVISED: MALE-FEMALE MIDSECTION (40MM). DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY: CANAL-FILLING SEGMENTAL STEM (11X152MM), TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION (12X100MM). NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12751632 ↗
• InjuryOct 28, 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 04 OCTOBER 2021 DUE TO AN ALLEGED INFECTION. THE PATIENT'S KNEE WAS DISCHARGING FLUID AND THE SURGEON WANTED TO TEST FOR AN INFECTION. DURING THE REVISION SURGERY, THE SURGEON PERFORMED A POLY SWAP AND A WASHOUT. THE FOLLOWING ELEOS IMPLANTS WERE REVISED DURING THE REVISION SURGERY: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, MALE-FEMALE MIDSECTION, CEMENTED SEGMENTAL STEM, TIBIAL BASEPLATE, CEMENTED STEM EXTENSION, AND RESURFACING PATELLA. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 12712510 ↗
• InjurySep 23, 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 FOLLOWING PART WERE REMOVED AND REVISED: DISTAL 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: TIBIAL BASEPLATE, DISTAL FEMUR, STEM EXTENSION, COLLAR, COLLAR LOCKING RING, AND CEMENTED STEM. THE SURGEON REMOVED IMPLANTS WITH POLY COMPONENTS AND PERFORMED INCISION AND DRAINAGE. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12523113 ↗
• InjuryJul 1, 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 PATIENT DEVELOPED AN ALLEGED INFECTION WITH SMITH & NEPHEW IMPLANTS THAT WERE IMPLANTED ON (B)(6) 2019 FOR AN UNKNOWN REASON. THE PATIENT UNDERWENT A FIRST STAGE REVISION SURGERY ON (B)(6) 2019 WHERE THE FOLLOWING ELEOS PARTS WERE IMPLANTED: TIBIAL HINGE COMPONENT WITH ROTATIONAL STOP, TIBIAL BASEPLATE, STEM EXTENSION, DISTAL FEMUR, TIBIAL BLOCK AUGMENT, DISTAL FEMUR AXIAL PIN, SEGMENTAL STEM, AND TIBIAL POLY SPACER. THE SECOND STAGE REVISION SURGERY TOOK PLACE ON (B)(6) 2021 WHERE THE FOLLOWING ELEOS COMPONENTS WERE REMOVED AND REPLACED: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. A WASHOUT WAS PERFORMED AND ADDITIONAL ANTIBIOTICS WERE INSERTED. THE FOLLOWING ELEOS COMPONENTS ARE STILL IMPLANTED: TIBIAL BASEPLATE, STEM EXTENSION, DISTAL FEMUR, TIBIAL BLOCK AUGMENT, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12099599 ↗
• InjuryJun 3, 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: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORGIINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: DISTAL FEMUR, FEMORAL HEAD, STEM EXTENSION, 140MM MALE-FEMALE MIDSECTION, 50MM MALE-FEMALE MIDSECTION, RESURFACING PATELLA, 50MM MALE-MALE MIDSECITON, TIBIAL BASEPLATE. AND A PROXIMAL FEMUR. THE SURGEON REMOVED IMPLANTS WITH POLY COMPONENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11935735 ↗
• InjuryOct 30, 2020Appropriate Device Problem Term/Code Not Available

  A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 PERFORMED BY DR. (B)(6) DUE TO SCAR TISSUE FORMING AROUND THE PATIENT'S PATELLA WHICH WAS CAUSING PAIN, STIFFNESS, AND A LOSS OF RANGE OF MOTION OF THE KNEE. THE SURGEON DEBRIDED THE SCAR TISSUE BUT DID NOT REPLACE THE IMPLANTS AS THEY WERE DEEMED TO NOT BE AFFECTED AND THERE WERE NO FAILURES FOUND INTRAOPERATIVELY.

  Patient problems: Scar Tissue

  MAUDE report 10766358 ↗

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-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-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-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