ELEOS™ KSC01665ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI B278KSC01665E0), received between Mar 25, 2020 and Nov 11, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2022Adverse 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) 2022 WHERE THE SURGEON REMOVED THE IMPLANTS, FLASHED THEM, AND RE-IMPLANTED THE SAME DEVICES. THE FOLLOWING ELEOS IMPLANTS WERE IMPLANTED AT THE TIME OF THE ALLEGED INFECTION: TIBIAL BASEPLATE, CEMENTED SEGMENTAL STEM, DISTAL FEMUR, CEMENTED STEM EXTENSION, MODULAR COLLAR LOCKING RING, MODULAR REDUCED RESECTION COLLAR, TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN.

  Patient problems: Unspecified Infection

  MAUDE report 15780716 ↗
• InjurySep 30, 2022Adverse 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) 2022 WHERE THE FOLLOWING ELEOS IMPLANTS WERE EXPLANTED: TIBIAL BASEPLATE, CEMENTED SEGMENTAL STEM, DISTAL FEMUR, CEMENTED STEM EXTENSION, MODULAR COLLAR LOCKING RING, MODULAR REDUCED RESECTION COLLAR, TIBIAL POLY SPACER, TIBIAL HINGE COMPONENT, AND DISTAL FEMUR AXIAL PIN. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15509584 ↗
• InjuryFeb 19, 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) 2022 DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE SURGEON REVISED THE FOLLOWING IMPLANTS: ELEOS TIBIAL HINGE COMPONENT, ELEOS TIBIAL POLY SPACER, AND GUARDIAN RESURFACING FEMUR AXIAL PIN. THE SURGEON PERFORMED A WASHOUT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: TIBIAL BASEPLATE, CEMENTED STEM EXTENSION (18X100MM), CEMENTED STEM EXTENSION (16X65MM), RESURFACING FEMUR, TIBIAL BASEPLATE TAPERED SCREW, AND RESURFACING FEMUR TAPERED SCREW. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS NOT BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13565392 ↗
• InjuryFeb 16, 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) 2022 DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE SURGEON REVISED THE FOLLOWING ELEOS IMPLANTS: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE SURGEON PERFORMED A WASHOUT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: TIBIAL BASEPLATE, CEMENTED STEM, DISTAL FEMUR, CEMENTED STEM EXTENSION, MODULAR COLLAR LOCKING RING, AND MODULAR REDUCED RESECTION COLLAR. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS NOT BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13546351 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SCHEDULED A REVISION SURGERY ON (B)(6) 2022 FOR A POLY SWAP AFTER HAVING A DISTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2021. THE REVISION SURGERY WAS CANCELLED AND HAS NOT BEEN RESCHEDULED. IT WAS CANCELLED DUE TO ALLEGED PATIENT ILLNESS. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13447634 ↗
• InjuryDec 6, 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 ON (B)(6) 2021 DUE TO AN ALLEGED INFECTION. THE SURGEON REVISED THE FOLLOWING ELEOS COMPONENTS: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, CEMENTED STEM EXTENSION, CEMENTED SEGMENTAL STEM, AND TIBIAL BASEPLATE. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12933260 ↗
• InjuryAug 30, 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 ON (B)(6) 2021 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: 2 TIBIAL BLOCK AUGMENTS, RESURFACING FEMUR, CEMENTED STEM EXTENSION (18MM X 100MM), CEMENTED STEM EXTENSION (16MM X 65MM), AND TIBIAL BASEPLATE. THE SURGEON PERFORMED A WASHOUT AND ADMINISTERED ANTIBIOTICS. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12385871 ↗
• InjuryMar 25, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION. THE SALES REPRESENTATIVE, PRESENT DURING THE SURGERY, RELAYED THAT UPON INTRAOPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE FEMORAL AND TIBIAL IMPLANTS HAD LOOSENED.

  Patient problems: Unspecified Infection

  MAUDE report 9878857 ↗

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-2425-2025 · Jul 11, 2025 · Open, Classified
  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. 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-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-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-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