ELEOS™ PF-2000R-02MRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI B278PF2000R02M0), received between May 7, 2022 and Mar 9, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A FRACTURE. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR.

  Patient problems: Periprosthetic fracture

  MAUDE report 24550728 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO A FRACTURE. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR.

  Patient problems: Periprosthetic fracture

  MAUDE report 24549170 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24148281 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  RETROSPECTIVE REPORT ENCOUNTERED THROUGH PATIENT'S PRIOR COMPLAINT HISTORY. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO UNKNOWN REASONS. COMPLAINT WILL BE REPORTED DUE TO REVISION SURGERY. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24111246 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. WASHOUT AND SWAPPED PROXIMAL FEMUR COMPONENT. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23816835 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23673901 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS PROXIMAL. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23584624 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 68-YEAR-OLD FEMALE PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. REPORTED THAT THE SURGEON SWAPPED MODULAR COMPONENTS. THIS REPORT CAPTURES THE ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23375855 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 58-YEAR-OLD MALE PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. REPORTED THAT THE SURGEON SWAPPED MODULAR COMPONENTS. THIS REPORT CAPTURES THE ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23353330 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 67-YEAR-OLD FEMALE PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES THE ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23037104 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN ELEOS PROXIMAL FEMURE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES THE ELEOS PROXIMAL FEMUR COMPONENT. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION SURGERY.

  Patient problems: Medical device site infection

  MAUDE report 22469719 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AN ONKOS DISTRIBUTOR, THAT A 77-YEAR-OLD MALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY DUE TO AN ALLEGED INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 20723113 ↗
• InjuryMay 15, 2024Adverse 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 IDENTIFIED THAT A PATIENT RECEIVED A REVISION PROCEDURE TO REMOVE AND REPLACE AN ELEOS PROXIMAL FEMUR, ELEOS MALE-FEMALE MIDSECTION, AND AN ELEOS SEGMENTAL STEM. THE REASON FOR REVISION IS UNKNOWN AT THIS TIME. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES THE REVISED ELEOS PROXIMAL FEMUR.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 19325994 ↗
• InjuryMay 15, 2024Adverse 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 IDENTIFIED THAT A PATIENT RECEIVED A REVISION PROCEDURE TO REMOVE AND REPLACE AN ELEOS MALE-FEMALE MIDSECTION, ELEOS PROXIMAL FEMUR, AND AN ELEOS MALE-FEMALE MIDSECTION. THE REASON FOR REVISION IS UNKNOWN AT THIS TIME. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES THE REVISED ELEOS PROXIMAL FEMUR.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 19325649 ↗
• InjuryMay 15, 2024Adverse 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 IDENTIFIED THAT A PATIENT RECEIVED A REVISION PROCEDURE TO REMOVE AND REPLACE AN ELEOS MALE-FEMALE MIDSECTION, ELEOS PROXIMAL FEMUR, AND AN ELEOS MALE-FEMALE MIDSECTION. THE REASON FOR REVISION IS UNKNOWN AT THIS TIME. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES THE REVISED ELEOS PROXIMAL FEMUR.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 19324837 ↗
• InjuryMay 15, 2024Adverse 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 IDENTIFIED THAT A PATIENT RECEIVED A REVISION PROCEDURE TO REMOVE AND REPLACE AN ELEOS PROXIMAL FEMUR. THE REASON FOR REVISION IS UNKNOWN AT THIS TIME. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES THE REVISED ELEOS PROXIMAL FEMUR.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 19324810 ↗
• InjuryMay 9, 2024Adverse 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 A PATIENT WILL BE REVISED DUE TO AN ALLEGED INFECTION. THE FOLLOWING IMPLANTS WILL BE REVISED: ELEOS PROXIMAL FEMUR, ELEOS MALE-FEMALE MIDSECTION, AND ELEOS CEMENTED SEGMENTAL STEM. THE DATE OF THE REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY, AS THE IMPLANTED DEVICES WILL BE REVISED. THIS REPORT CAPTURES THE ELEOS PROXIMAL FEMUR.

  Patient problems: Unspecified Infection

  MAUDE report 19281847 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 05 SEPTEMBER 2023 THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023, DUE TO A POTENTIAL INFECTION. THE PATIENT WAS IMPLANTED WITH THE ELEOS PROXIMAL FEMUR SYSTEM. DURING THE REVISION PROCEDURE, THE ELEOS PROXIMAL FEMUR AND ELEOS MALE-FEMALE MIDSECTION WERE REMOVED AND REPLACED. THE PATIENT'S ORIGINAL SURGERY DATE IS NOT KNOWN AT THIS TIME; THEREFORE, DEVICE SPECIFIC INFORMATION IS NOT KNOWN. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE, THIS REPORT CAPTURES THE ELEOS PROXIMAL FEMUR.

  Patient problems: Unspecified Infection

  MAUDE report 17877570 ↗
• InjuryJun 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S FEMORAL HEAD DISLOCATED. THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TWO MALE-FEMALE MIDSECTIONS AND PROXIMAL FEMUR. THE PATIENT'S FEMORAL HEAD WAS MANUFACTURED BY A DIFFERENT COMPANY AND WAS ALSO REVISED DURING THIS REVISION SURGERY. THE TWO 40MM ELEOS MALE-FEMALE MIDSECTIONS WERE REVISED TO A 70MM ELEOS MALE-FEMALE MIDSECTION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17148512 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER, ELEOS DISTAL FEMUR AXIAL PIN AND ELEOS DISTAL FEMUR. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: CANAL-FILLING STEM EXTENSION, TIBIAL BASEPLATE, MALE-FEMALE MIDSECTIONS, MALE-MALE MIDSECTION, AND PROXIMAL FEMUR. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16482876 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2023 DUE TO AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER AND ELEOS DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 16297134 ↗
• InjuryMay 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 DUE TO A FAILURE OF THE ACETABULAR CAGE. DURING THE REVISION SURGERY, THE PROXIMAL FEMUR WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14324278 ↗

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-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-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-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
• 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