ELEOS™ 25002101ERecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI B27825002101E0), received between Sep 7, 2018 and Jul 20, 2023 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE POST OF THE PATIENT'S TIBIAL HINGE COMPONENT FRACTURED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 AND THE FOLLOWING IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, POLY SPACER, AND DISTAL FEMUR AXIAL PIN. IMAGES OF THE EXPLANTED IMPLANTS IDENTIFIED THAT THERE WAS DAMAGE TO THE TOP OF THE TIBIAL POLY SPACER. IT WAS REPORTED THAT THERE WAS SUSPECTED METAL DEBRIS FROM THE TIBIAL HINGE COMPONENT FRACTURE. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17367977 ↗
• 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 13500632 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ALLEGED DISASSOCIATED STEM ON THE RESURFACING FEMUR AND AN ALLEGED INFECTION ON (B)(6) 2022, AFTER RECEIVING A PROXIMAL TIBIA REPLACEMENT SURGERY ON (B)(6) 2020. THE IMPLANTING SURGEON PERFORMED REVISION SURGERIES ON THE PATIENT TO WASH THE PATIENT OUT ON (B)(6) 2022. THE SURGEON ALSO PERFORMED A REVISION SURGERY ON (B)(6) 2022 TO REMOVE ALL THE IMPLANTS THAT WERE IMPLANTED ON (B)(6) 2020 DURING THE ORIGINAL THE PROXIMAL TIBIA REPLACEMENT SURGERY. IT WAS ALSO REPORTED THAT THE SURGEON PLANS TO PUT IN REPLACEMENT IMPLANTS WHEN THE INFECTION CLEARS UP. NO REVISION SURGERY TO DO THIS HAS BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13458655 ↗
• 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 (18 X 140MM), TIBIAL BASEPLATE, AND CANAL-FILLING STEM EXTENSION (18 X 100MM). NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13307228 ↗
• 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 12751641 ↗
• 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 12441361 ↗
• 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 12016805 ↗
• InjuryMay 21, 2021Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  THE PATIENT INVOLVED IN THIS COMPLAINT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6). IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT PULLED OUT THEIR SURGICAL DRAIN WHEN THE DRAIN WAS SUPPOSED TO REMAIN IN THE PATIENT ACCORDING TO POST-OPERATIVE INSTRUCTIONS. THE DRAIN WAS PLACED ON (B)(6) 2021 DURING A SURGERY PERFORMED BY DR. (B)(6) TO PLACE ELEOS COMPONENTS FOR AN UNKNOWN REASON. DURING THE REVISION SURGERY, THE PATIENT HAD ELEOS COMPONENTS EXPLANTED AND REPLACED. THERE WAS NO REPORTED FAILURE OF THE ELEOS COMPONENTS. IT IS UNKNOWN AT THIS TIME WHY THE COMPONENTS WERE REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 11866621 ↗
• InjuryMay 21, 2021Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  THE PATIENT INVOLVED IN THIS COMPLAINT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6). IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT PULLED OUT THEIR SURGICAL DRAIN WHEN THE DRAIN WAS SUPPOSED TO REMAIN IN THE PATIENT ACCORDING TO POST-OPERATIVE INSTRUCTIONS. THE DRAIN WAS PLACED ON (B)(6) 2021 DURING A SURGERY PERFORMED BY DR. (B)(6) TO PLACE ELEOS COMPONENTS FOR AN UNKNOWN REASON. DURING THE REVISION SURGERY, THE PATIENT HAD ELEOS COMPONENTS EXPLANTED AND REPLACED. THERE WAS NO REPORTED FAILURE OF THE ELEOS COMPONENTS. IT IS UNKNOWN AT THIS TIME WHY THE COMPONENTS WERE REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866590 ↗
• MalfunctionApr 22, 2021Break

  A PATIENT WAS UNDERGOING A SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6) TO PLACE A DISTAL FEMUR IMPLANT. WHEN THE SURGEON ATTEMPTED TO PLACE A DISTAL FEMUR AXIAL PIN TO JOIN THE DISTAL FEMUR IMPLANT AND THE TIBIAL HINGE COMPONENT, THE POLY COMPONENT OF THE DISTAL FEMUR AXIAL PIN BROKE OFF OF THE IMPLANT. THIS LED TO A SHORT DELAY IN SURGERY OF LESS THAN FIFTEEN MINUTES WHILE A REPLACEMENT DISTAL FEMUR AXIAL PIN WAS RETRIEVED AND IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 11711727 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem

  A 39-YEAR-OLD MALE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 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 AND REVISED A DISTAL FEMUR COMPONENT, A TIBIAL POLY SPACER, A TIBIAL HINGE COMPONENT, AND A DISTAL FEMUR AXIAL PIN WITH IDENTICAL IMPLANTS.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 10843770 ↗
• InjuryOct 30, 2020Appropriate Device Problem Term/Code Not Available

  A (B)(6) 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 10762595 ↗
• 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 10671693 ↗
• InjuryJul 1, 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 10220693 ↗
• 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 9745007 ↗
• InjuryFeb 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 ALLEGED INFECTION AND THE FEMORAL STEM LOOSENING.

  Patient problems: Unspecified Infection

  MAUDE report 9707220 ↗
• InjuryFeb 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 ALLEGED INFECTION AND THE FEMORAL STEM LOOSENING.

  Patient problems: Unspecified Infection

  MAUDE report 9706916 ↗
• InjuryFeb 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT ALLEGED THAT THEIR TIBIAL HINGE COMPONENT DISLOCATED, BUT WHEN THEY VISITED THEIR SURGEON IT APPEARED THAT IT HAD REDUCED ITSELF WITHOUT SURGICAL INTERVENTION. PATIENT'S INCISION SITE WAS EXTREMELY RED AND INFLAMED AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 9700011 ↗
• 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 9356282 ↗
• InjurySep 18, 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: Unspecified Infection

  MAUDE report 9083120 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SIGNS OF AN ALLEGED INFECTION, WHICH REQUIRED SURGICAL INTERVENTION TO WASH OUT THE JOINT AND REPLACE IMPLANTS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 8712985 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUFFERED A FALL, WHICH CAUSED THEIR INCISION TO STRETCH OPEN. A REVISION SURGERY WAS PERFORMED TO REPLACE THREE COMPONENTS.

  Patient problems: Fall

  MAUDE report 8651249 ↗
• InjuryMay 1, 2019Fracture; Fracture

  PATIENT'S KNEE GAVE OUT CAUSING PAIN AND DISLOCATION OF THEIR KNEE. X-RAYS REVEALED THAT THE TIBIAL HINGE COMPONENT HAD FRACTURED, WHICH REQUIRED SURGICAL INTERVENTION. DURING THE REVISION, THE TIBIAL POLY SPACER WAS ALSO REVISED AND WAS IDENTIFIED AS DAMAGED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 8568959 ↗
• 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 7855619 ↗

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-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-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-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