ELEOS Limb Salvage System CS-13120-03MRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI B278CS1312003M0), received between Sep 10, 2021 and May 1, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 67-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION ON (B)(6) 2026 DUE TO LOOSENING. PATIENT FELL AND STEM. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening; Fall

  MAUDE report 25057501 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23821968 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23821966 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY M. POST, AN ONKOS DISTRIBUTOR, THAT A 15-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ASEPTIC LOOSENING OF A CEMENTED SEGMENTAL STEM. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Aseptic loosening

  MAUDE report 23744565 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23526961 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY B. MATSON, AN ONKOS SALES REPRESENTATIVE, THAT AN 81-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE INFECTION. THE ELEOS CANAL FILLING SEGMENTAL STEM REPORTEDLY LOOSE AND WAS REPLACED DURING REVISION.

  Patient problems: Medical device site infection

  MAUDE report 20788255 ↗
• InjuryMay 9, 2024Adverse 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 A PATIENT WILL BE REVISED DUE TO AN ALLEGED INFECTION. THE FOLLOWING IMPLANTS WILL BE REVISED: ELEOS PROXIMAL FEMUR, ELEOS MALE-FEMALE MIDSECTION, AND ELEOS CEMENTED SEGMENTAL STEM. THE DATE OF THE REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY, AS THE IMPLANTED DEVICES WILL BE REVISED. THIS REPORT CAPTURES THE ELEOS CEMENTED SEGMENTAL STEM.

  Patient problems: Unspecified Infection

  MAUDE report 19281846 ↗
• InjuryAug 31, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 DUE TO A SUSPECTED LOOSENING OF THEIR 13X120MM STRAIGHT CEMENTED SEGMENTAL STEM. DURING THE REVISION SURGERY, THE PATIENT'S PROXIMAL FEMORAL REPLACEMENT SYSTEM WAS REVISED TO A TOTAL FEMORAL REPLACEMENT SYSTEM. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17666908 ↗
• InjuryAug 24, 2023Adverse 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. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: STEM EXTENSION, SEGMENTAL STEM, DISTAL FEMUR, MALE-FEMALE MIDSECTION, AND TIBIAL BASEPLATE. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17619626 ↗
• MalfunctionNov 23, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2022, IT WAS IDENTIFIED THAT THE PACKAGING OF THE CEMENTED SEGMENTAL STEM WAS DAMAGED AND NO LONGER SEALED. UPON OPENING THE BOX, THIS MALFUNCTION WAS IDENTIFIED AND THE DEVICE WAS NOT USED. THE SURGEON IMPLANTED A DIFFERENT SEGMENTAL STEM. NO ADDITIONAL INFORMATION REGARDING THIS MALFUNCTION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851572 ↗
• InjuryOct 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY FOR A POLY SWAP OF ELEOS IMPLANTS. IT IS LIKELY THAT THE PATIENT'S IMPLANTED ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL HINGE COMPONENTS, AND ELEOS POLYSPACER WERE REMOVED AND REPLACED. ON 23 SEPTEMBER 2022, ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS EVENT: IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLEGED INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION SURGERY, THE SURGEON REVISED THE TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S SURGERY ON (B)(6) 2022: DISTAL FEMUR, MALE-FEMALE MIDSECTION, CEMENTED SEGMENTAL STEM, CANAL-FILLING SEGMENTAL STEM, TIBIAL BASEPLATE, TWO TIBIAL BLOCK AUGMENTS, AND A CEMENTED STEM EXTENSION. ALL PARTS IMPLANTED AT THE TIME OF INFECTION WILL BE REPORTED. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY DUE TO THE REVISION. THIS RECORD CAPTURES THE ELEOS CEMENTED SEGMENTAL STEM.

  Patient problems: Unspecified Infection

  MAUDE report 15656624 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY. THE FOLLOWING IMPLANTS WERE REMOVED DURING THE REVISION: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL BASEPLATE, ELEOS TIBIAL POLY SPACER, ELEOS TIBIAL HINGE W/ ROTATIONAL STOP, ELEOS STEM EXTENSION, ELEOS DISTAL FEMUR, ELEOS TIBIAL BLOCK AUGMENT AND ELEOS CEMENTED SEGMENTAL STEM.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15298675 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH ONKOS DEVICES ON (B)(6) 2022. AN ONKOS CUSTOM ADAPTOR WAS CREATED TO CONNECT TO THE PATIENT'S PREVIOUSLY EXISTING HARDWARE TO THE ONKOS DISTAL FEMUR REPLACEMENT SYSTEM. IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2022 DUE TO AN INFECTION. THE FOLLOWING IMPLANTED DEVICES WERE REMOVED DURING THE REVISION PROCEDURE: CUSTOM COMPRESS ADAPTOR, ELEOS TIBIAL HINGE, ELEOS TIBIAL POLY SPACER, ELEOS TIBIAL BASEPLATE, ELEOS TIBIAL BASEPLATE TAPERED SCREW, TWO ELEOS MALE-FEMALE MIDSECTIONS, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR, AND AN ELEOS TIBIAL BASEPLATE. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 14649411 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 THE PATIENT RECEIVED A SUPERFICIAL WOUND DEBRIDEMENT TO TREAT A SUPERFICIAL SUTURE AND SUB-Q ABSCESS THAT DEVELOPED AFTER RECEIVING DISTAL FEMORAL REPLACEMENT SURGERY.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 14138164 ↗
• InjurySep 10, 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) DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE FOLLOWING IMPLANTS WERE REVISED: ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR, ELEOS TIBIAL POLY SPACER, ELEOS SEGMENTAL STEM, AND ELEOS TIBIAL HINGE COMPONENT. NO FURTHER INFORMATION REGARDING THIS EVENT WAS MADE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12454617 ↗

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-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-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-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
• 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