ELEOS™ Limb Salvage System THSMWOS01MRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI B278THSMWOS01M0), received between Sep 10, 2021 and Jun 10, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse 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) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 25457131 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 24940591 ↗
• InjuryMar 26, 2026Adverse 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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24701921 ↗
• InjuryJan 21, 2026Adverse 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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24138399 ↗
• InjuryJan 14, 2026Adverse 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. NO PRIOR POST BILL WAS FOUND OF UNKNOWN PATIENT. THE DEVICES WILL BE REPORTED WITH UNKNOWN LOT NUMBERS. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24069082 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23981836 ↗
• InjuryDec 23, 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 TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23878674 ↗
• InjuryNov 18, 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 A LONG TERM PAIN. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Limb Pain

  MAUDE report 23585520 ↗
• InjuryOct 27, 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 76-YEAR-OLD MALE PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO A DISLOCATION OF THE TIBIAL POLY SPACER. THIS REPORT CAPTURES THE ELEOS TIBIAL HINGE. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 23393334 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS A REVISION OF AN ELEOS DISTAL FEMUR REPLACEMENT IN AN 57-YEAR-OLD MALE PATIENT DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 22133258 ↗
• InjuryMay 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AN ONKOS SALES REPRESENTATIVE REPORTED THAT A 78-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 22079841 ↗
• InjuryMay 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AN ONKOS SALES REPRESENTATIVE REPORTED THAT A 78-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 22079840 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 78-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ALLEGED PERIPROSTHETIC JOINT INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21860859 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4), AN ONKOS SALES REPRESENTATIVE, THAT A 54-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO AN ALLEGED PERI-OPERATIVE INFECTION. IT WAS NOTED THAT THE HOSPITAL STAFF INADVERTENTLY PERFORATED THE WOUND SITE WITH A COTTON SWAB POST-OPERATIVELY.

  Patient problems: Medical device site infection

  MAUDE report 21043453 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HISTORICAL ADVERSE EVENT WAS DISCOVERED DURING THE INVESTIGATION OF (B)(4), WHEREIN A 68-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 21029224 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6), AN ONKOS DISTRIBUTOR, THAT A 43-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 20517461 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(4), AN ONKOS DISTRIBUTOR, THAT A 43-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF THE ELEOS CEMENTED SEGMENTAL STEM THAT WAS INSERTED INTO THE FEMUR WITHOUT THE USE OF BONE CEMENT. THE REPORTED INFORMATION ALSO INDICATED THAT THE ELEOS TIBIAL BASEPLATE WAS ALSO INSERTED WITHOUT BONE CEMENT AND THE SURGEON SUSPECTED THAT THE PATIENT HAD A PERI-OPERATIVE INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 20476178 ↗
• InjuryAug 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6) AN ONKOS SALES REPRESENTATIVE, THAT A 16-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO A POSSIBLE INFECTION WHICH IS BELIEVED TO BE PREVENTING THE PATIENT'S WOUND FROM HEALING.

  Patient problems: Medical device site infection

  MAUDE report 19999365 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY(B)(6), AN ONKOS SALES REPRESENTATIVE, THAT AN 18-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT INCLUDING AN ELEOS PROXIMAL TIBIA UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE SURGEON, DOCTOR (B)(6), WASHED OUT THE OPERATIVE JOINT AND REPLACED THE ELEOS DEVICES LISTED ABOVE.

  Patient problems: Medical device site infection

  MAUDE report 19373646 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY M. SANSUM, AN ONKOS SALES REPRESENTATIVE, THAT AN 81-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED JOINT INFECTION ON (B)(6) 2024. THE PATIENT HAD REPORTEDLY FALLEN AND SCRAPED HER KNEE WHICH BECAME INFECTED AND LED TO THE JOINT INFECTION. ALL IMPLANTS IDENTIFIED IN THE TABLE ABOVE WERE REPLACED DURING THE WASHOUT.

  Patient problems: Medical device site infection

  MAUDE report 19073109 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY SAVANNAH BOYD, AN ONKOS DISTRIBUTOR, THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS AN ALLEGED INFECTION. THE SURGERY TOOK PLACE ON (B)(6) 2024 AND IS THE SECOND REVISION SURGERY FOR THIS PATIENT IN WHICH ELEOS DEVICES WERE REVISED. AT THE TIME OF THIS REVISION SURGERY, THE THEN 55-YEAR-OLD FEMALE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT HAD NINE (9) ELEOS COMPONENTS EXPLANTED AND REPLACED EXCEPT FOR THE FEMORAL HEAD WHICH WAS REPLACED WITH A NON-ONKOS DEVICE.

  Patient problems: Medical device site infection

  MAUDE report 18989335 ↗
• InjurySep 7, 2023Adverse 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. A REVISION SURGERY HAS NOT YET BEEN SCHEDULED. THE PATIENT HAS THE FOLLOWING ELEOS DEVICES IMPLANTED: TIBIAL POLY SPACER, DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, STEM EXTENSION, THREE MALE-FEMALE MIDSECTIONS, PROXIMAL FEMUR, AND MALE-MALE MIDSECTION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17704065 ↗
• InjuryJul 21, 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 AND REPLACED DURING THE REVISION: ELEOS TIBIAL HINGE, ELEOS TIBIAL POLY SPACER, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS DISTAL FEMUR AND 2 X ELEOS MALE-FEMALE MIDSECTIONS. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15079957 ↗
• InjuryOct 28, 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 PATIENT'S KNEE WAS DISCHARGING FLUID AND THE SURGEON WANTED TO TEST FOR AN INFECTION. DURING THE REVISION SURGERY, THE SURGEON PERFORMED A POLY SWAP AND A WASHOUT. THE FOLLOWING ELEOS IMPLANTS WERE REVISED DURING THE REVISION SURGERY: TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, AND TIBIAL POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL SURGERY: DISTAL FEMUR, MALE-FEMALE MIDSECTION, CEMENTED SEGMENTAL STEM, TIBIAL BASEPLATE, CEMENTED STEM EXTENSION, AND RESURFACING PATELLA. NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN PROVIDED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 12712517 ↗
• 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) 2021 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 12454604 ↗

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-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-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
• 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