ELEOS™ KSP17100ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B278KSP17100E0), received between Jan 2, 2018 and May 11, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 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.

• InjuryMay 11, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 DUE TO AN ALLEGED LOOSENING OF THE PATIENT'S 18X100MM CANAL-FILLING STEM EXTENSION. DURING THE REVISION SURGERY, THE PATIENT'S RESURFACING FEMUR, RESURFACING FEMUR AXIAL PIN, AND 18X100MM CANAL-FILLING STEM EXTENSION WERE REVISED TO A DISTAL FEMUR, DISTAL FEMUR AXIAL PIN, AND 13X120MM CEMENTED SEGMENTAL STEM. THE FOLLOWING IMPLANTS WERE ALSO REVISED: TIBIAL HINGE COMPONENT AND TIBIAL POLY SPACER. THERE WERE NO ALLEGED MALFUNCTIONS WITH THE RESURFACING FEMUR, RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16915338 ↗
• InjuryMay 21, 2021Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  THE PATIENT INVOLVED IN THIS COMPLAINT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6). IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT PULLED OUT THEIR SURGICAL DRAIN WHEN THE DRAIN WAS SUPPOSED TO REMAIN IN THE PATIENT ACCORDING TO POST-OPERATIVE INSTRUCTIONS. THE DRAIN WAS PLACED ON (B)(6) 2021 DURING A SURGERY PERFORMED BY DR. (B)(6) TO PLACE ELEOS COMPONENTS FOR AN UNKNOWN REASON. DURING THE REVISION SURGERY, THE PATIENT HAD ELEOS COMPONENTS EXPLANTED AND REPLACED. THERE WAS NO REPORTED FAILURE OF THE ELEOS COMPONENTS. IT IS UNKNOWN AT THIS TIME WHY THE COMPONENTS WERE REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 11866634 ↗
• InjuryMar 19, 2018Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component; Device Dislodged or Dislocated

  A REVISION SURGERY WAS PERFORMED TO DRAIN AND IRRIGATE THE KNEE DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, IT WAS FOUND THAT THE RESURFACING FEMUR HAD LOOSENED AND DISSOCIATED FROM THE STEM EXTENSION.

  Patient problems: Unspecified Infection

  MAUDE report 7350367 ↗
• InjuryFeb 16, 2018Device Slipped; Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT WITH ELEOS REVISION HINGE, HEARD A SNAPPING/POPPING NOISE COME FROM THEIR KNEE WHILE DOING SQUATS AT PHYSICAL THERAPY. A REVISION SURGERY WAS PERFORMED DUE TO ARTHROFIBROSIS, FAILED TOTAL KNEE AND MORBID OBESITY, TO REMOVE EXCESS SCAR TISSUE AND PERFORM A POLY SWAP. UPON INSPECTING THE JOINT, THE SURGEON NOTICED A FREE PIECE OF CEMENT AND THAT THE CEMENTED RESURFACING FEMUR HAD LOOSENED AND DISSOCIATED FROM THE STEM EXTENSION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Disorder; No Information; Scar Tissue

  MAUDE report 7278343 ↗
• InjuryJan 2, 2018Loss of Osseointegration; Detachment of Device or Device Component; Device Dislodged or Dislocated; Loss of Osseointegration; Detachment of Device or Device Component

  PATIENT WITH ELEOS REVISION HINGE, HEARD A SNAPPING/POPPING NOISE COME FROM THEIR KNEE WHILE DOING SQUATS AT PHYSICAL THERAPY. A REVISION SURGERY WAS PERFORMED TO REMOVE EXCESS SCAR TISSUE AND EXCHANGE THE POLY COMPONENTS FOR A THICKER SPACER. DURING SURGERY THE SURGEON NOTICED THAT THE CANAL FILLING STEM HAD DISSOCIATED FROM THE INTERMEDULLARY CANAL. THE CANAL FILLING STEM WAS REMOVED AND A CEMENTED STEM WAS IMPLANTED.

  Patient problems: No Code Available; No Information

  MAUDE report 7156567 ↗

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-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-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-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
• 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