ELEOS Limb Salvage System FS-11120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278FS1112003M0), received between Apr 20, 2021 and Jun 26, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 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 STEM FRACTURE. IT WAS REPORTED THAT PATIENT STARTED HAVING HIP PAIN FIVE WEEKS PRIOR TO SURGERY. THIS REPORT CAPTURES ELEOS FEMORAL STEM.

  Patient problems: External Prosthetic Device Pain; Periprosthetic fracture

  MAUDE report 25636452 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2025 AND PRESENTED EVIDENCE OF LOOSENING AROUND THE FEMORAL STEM.

  Patient problems: Aseptic loosening

  MAUDE report 25325136 ↗
• 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 FEMORAL STEM.

  Patient problems: Periprosthetic fracture

  MAUDE report 24550731 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ALLEGED INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE FOLLOWING IMPLANTS WERE REVISED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP AND ELEOS TIBIAL POLY SPACER.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 16028294 ↗
• InjuryApr 20, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DOCTOR. (B)(6) DUE TO A FEMORAL CANAL-FILLING SEGMENTAL STEM LOOSENING. THE SEGMENTAL STEM WAS PLACED DURING THE PATIENT'S PRIMARY ELEOS SURGERY WHICH WAS ALSO PERFORMED BY (B)(6). THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON WAS HAVING TROUBLE PLACING THE STEM, SO HE REAMED THE PATIENT'S FEMUR ONE HALF OF A MILLIMETER MORE THAN WAS RECOMMENDED BY THE SURGICAL TECHNIQUE. THE SALES REPRESENTATIVE, (B)(6), STATED THAT HE ADVISED THE SURGEON OF THIS, BUT THE SURGEON STILL REAMED THE FEMUR MORE THAT WAS RECOMMENDED. PRIOR TO THE REVISION SURGERY, THE PATIENT WAS FOUND TO HAVE HIS FEMORAL STEM LOOSENING AND A REVISION SURGERY WAS PERFORMED. DURING THE REVISION, THE CANAL-FILLING STEM AS EXPLANTED AND A CEMENTED STEM WITH HE SAME DIMENSIONS OF 11X120MM WAS PLACED. THE LOOSENING WAS ASEPTIC, AND NO INFECTION WAS FOUND.

  Patient problems: Failure of Implant

  MAUDE report 11693838 ↗

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-2423-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. 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-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-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-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