ELEOS™ KSP15140ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278KSP15140E0), received between Sep 6, 2018 and Jan 20, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• 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 13307227 ↗
• 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 12016790 ↗
• InjuryApr 23, 2021Positioning Problem; Therapeutic or Diagnostic Output Failure

  AN UNKNOWN PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6). DUE TO HIP INSTABILITY. DURING SURGERY, THE SURGEON ATTEMPTED TO PLACE A STEM EXTENSION IN THE PATIENT'S TIBIA. THE STEM EXTENSION WAS UNABLE TO BE PLACED. IT IS NOT KNOWN WHY THE STEM EXTENSIONS WAS NOT ABLE TO BE PLACED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11716326 ↗
• InjuryApr 17, 2021Appropriate Device Problem Term/Code Not Available

  A PATIENT UNDERWENT A REVISION SURGERY ON 18 MARCH 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 FOR SURGERY ON (B)(6) 2021 TO HAVE ELEOS IMPLANTS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 11683012 ↗
• InjurySep 6, 2018Detachment of Device or Device Component; 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 7850339 ↗

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-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-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-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
• 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