ELEOS Limb Salvage System FB-16152-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI B278FB1615203M0), received between Apr 2, 2020 and Jan 14, 2026 — classified as 6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 24068171 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 24067467 ↗
• InjuryJun 19, 2023Adverse 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 (B)(6) 2023 WHERE THE FOLLOWING ELEOS IMPLANTS WERE REVISED: DISTAL FEMUR AXIAL PIN, TIBIAL POLY SPACER, DISTAL FEMUR, AND TIBIAL HINGE COMPONENT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: STEM EXTENSION, MALE-FEMALE MIDSECTION, TIBIAL BASEPLATE, AND SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17153465 ↗
• InjuryApr 17, 2021Appropriate Device Problem Term/Code Not Available

  A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6) DUE TO METAL DEBRIS IN THE SOFT TISSUE ENVELOPE. THE SURGEON REMOVED THE IMPLANTS AND WASHED OUT THE AREA TO REMOVE THE METAL DEBRIS. DURING THE OPERATION, IT WAS DETERMINED THAT THE PATIENT ALSO HAD AN INFECTION AROUND THE IMPLANTS. BLOOD WORK DETERMINED THAT THE CHROMIUM LEVELS IN THE PATIENT'S BLOOD WERE HIGH AT APPROXIMATELY 11 [?]G[?]L. NORMAL BLOOD CHROMIUM LEVELS ARE LESS THAN OR EQUAL TO 1.4 [?]G[?]L. ALL OF THE IMPLANTS WERE REMOVED EXCEPT FOR THE FEMORAL STEM WHICH WAS LEFT IN PLACE DUE TO THE SURGEON BELIEVING THAT IT WOULD NEGATIVELY AFFECT THE PATIENT'S FEMUR IF THEY REMOVED IT. THE PATIENT RETURNED TO SURGERY ON (B)(6) 2021 TO HAVE NEW IMPLANTS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 11683016 ↗
• InjurySep 11, 2020Appropriate Device Problem Term/Code Not Available

  A PATIENT UNDERWENT A REVISION SURGERY PERFORMED BY (B)(6) ON (B)(6) 2020 AT (B)(6) DUE TO AN INFECTION. THE PATIENT UNDERWENT AN INCISION AND DRAINAGE PROCEDURE IN AN ATTEMPT TO CLEAN THE INFECTED AREA. A NEW MIDSECTION AND SEGMENTAL STEM WERE PLACED AFTER EXPLANTING THE PREVIOUSLY IMPLANTED COMPONENTS TO FACILITATE REMOVAL OF THE INFECTION. THE MIDSECTION THAT WAS PLACED DURING THE PREVIOUS REVISION SURGERY WAS 110MM IN LENGTH AND IT WAS REPLACED WITH A 140MM MIDSECTION. THIS WAS DONE FOR AN UNKNOWN REASON.

  Patient problems: Unspecified Infection

  MAUDE report 10520825 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A REVISION SURGERY DUE TO A BONE FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9918331 ↗

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-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-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-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-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
• 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