ELEOS™ 2500R002ERecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI B2782500R002E0), received between Jun 8, 2018 and Jan 20, 2022 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 13307230 ↗
• InjuryJan 5, 2022Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE PATIENT PRESENTED WITH VARUS/VALGUS INSTABILITY. DURING THE REVISION SURGERY, IT WAS OBSERVED THAT THE STEM EXTENSION DISSOCIATED FROM THE RESURFACING FEMUR. IT WAS OBSERVED THAT THE BOSS OF THE RESURFACING FEMUR WAS CRACKED. THE SURGEON DEBRIDED THE WOUND AND EXPLANTED THE FOLLOWING IMPLANTS: POLY SPACER, RESURFACING FEMUR, TIBIAL HINGE COMPONENT, RESURFACING FEMUR AXIAL PIN, AND STEM EXTENSION. THE SURGEON PLACED A DISTAL FEMORAL REPLACEMENT SYSTEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 13168650 ↗
• InjuryAug 20, 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 (23MM X 100MM). 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 12349228 ↗
• 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 12016756 ↗
• MalfunctionOct 5, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2020, A (B)(6) FEMALE UNDERWENT A REVISION SURGERY DUE TO DISSOCIATION OF STEM EXTENSION AND RESURFACING FEMUR DISSOCIATED. DURING THE REVISION SURGERY, THE TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER, RESURFACING FEMUR, AND RESURFACING FEMUR AXIAL PIN WERE ALL REPLACED WITH IDENTICAL IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 10631543 ↗
• InjuryMay 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT UNDERWENT A REVISION SURGERY DUE TO THE RESURFACING FEMUR AND STEM EXTENSION DISSOCIATING.

  Patient problems: No Information

  MAUDE report 10059058 ↗
• 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 10009605 ↗
• InjuryMar 10, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO KNEE PAIN AND UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE FEMUR AND STEM HAD LOOSENED.

  Patient problems: Pain

  MAUDE report 9813776 ↗
• InjuryJul 10, 2019Loss of Osseointegration; Detachment of Device or Device Component; Loss of Osseointegration; Detachment of Device or Device Component

  PATIENT UNDERWENT A REVISION SURGERY DUE TO A DISSOCIATED RESURFACING FEMUR AND STEM EXTENSION.

  Patient problems: No Information

  MAUDE report 8777234 ↗
• InjurySep 6, 2018Loss of Osseointegration; Detachment of Device or Device Component; Loss of Osseointegration; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED ON ELEOS RESURFACING KNEE WHERE IT APPEARED ON X-RAYS THAT THE RESURFACING FEMUR AND STEM EXTENSION HAD DISSOCIATED.

  Patient problems: No Information

  MAUDE report 7850340 ↗
• InjuryAug 8, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY. DURING INTRAOPERATIVE INSPECTION IT WAS FOUND THAT THE RESURFACING FEMUR HAD LOOSENED.

  Patient problems: Failure of Implant

  MAUDE report 7765403 ↗
• InjuryJun 8, 2018Loss of or Failure to Bond; Detachment Of Device Component; Loss of Osseointegration; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment Of Device Component; Loss of Osseointegration; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED ON ELEOS RESURFACING HINGE KNEE WHERE IT APPEARED ON X-RAYS THAT THE RESURFACING FEMUR AND STEM EXTENSION HAD DISSOCIATED. UPON REMOVAL OF THE COMPONENTS IT WAS DISCOVERED THAT THE RESURFACING FEMUR HAD ALSO LOOSENED.

  Patient problems: Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 7582367 ↗

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-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-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-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-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