ELEOS™ KSP17140ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI B278KSP17140E0), received between Jul 10, 2019 and Mar 17, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE RESURFACING FEMUR AND STEM EXTENSION HAD BECOME LOOSE DUE TO POOR BONE QUALITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 WHERE THE PATIENT'S HINGE KNEE REPLACEMENT SYSTEM WAS REVISED TO A DISTAL FEMORAL REPLACEMENT SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 16566190 ↗
• MalfunctionOct 9, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  A (B)(6) MALE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 PERFORMED BY DR. (B)(6) DUE TO DISSOCIATION OF THE RESURFACING FEMUR COMPONENT AND FEMORAL STEM EXTENSION COMPONENT. DURING THE REVISION, THE SURGEON REPLACED THE RESURFACING FEMUR COMPONENT, THE RESURFACING FEMUR AXIAL PIN, AND THE STEM EXTENSION COMPONENT WITH A DISTAL FEMUR COMPONENT, DISTAL FEMUR AXIAL PIN, AND A SEGMENTAL STEM COMPONENT RESPECTIVELY. THE SURGEON ALSO REPLACED A TIBIAL HINGE COMPONENT DURING THE REVISION.

  Patient problems: Insufficient Information

  MAUDE report 10659087 ↗
• InjurySep 2, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISSOCIATION OF THE RESURFACING FEMUR COMPONENT AND THE STEM EXTENSION COMPONENT THAT WERE IMPLANTED IN THEIR LEFT LEG BY DR. (B)(6) AT THE (B)(6) ON (B)(6) 2020. THE RESURFACING FEMUR COMPONENT WAS EXPLANTED AND REPLACED. THE STEM EXTENSION COMPONENT WAS LEFT IN PLACE.

  Patient problems: Pain

  MAUDE report 10483147 ↗
• InjuryJul 10, 2019Detachment of Device or Device Component; 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 8777233 ↗

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-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-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-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-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