ELEOS™ PT-20000-02MRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI B278PT2000002M0), received between Mar 1, 2021 and Jan 22, 2026 — classified as 19 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (3 reports).

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24147147 ↗
• 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 PROXIMAL TIBIA. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23821985 ↗
• 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 PROXIMAL TIBIA. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23526933 ↗
• InjuryNov 4, 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. SURGEON WASHED OUT AND SWAPPED ALL MODULAR COMPONENTS. THIS REPORT CAPTURES ELEOS PROXIMAL TIBIA. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23466205 ↗
• InjurySep 10, 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 74-YEAR-OLD FEMALE PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT AND ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION REPLACING ALL COMPONENTS EXCEPT THE STEMS. THIS REPORT CAPTURES THE ELEOS PROXIMAL TIBIA. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 23022080 ↗
• InjuryMar 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 58-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR AND PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21713502 ↗
• InjuryNov 5, 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 56-YEAR-OLD MALE PATIENT WITH AN ELEOS TOTAL FEMUR & PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO A DISLOCATION OF THE TIBIAL POLY SPACER AND TIBIAL ROTATIONAL HINGE FROM THE PROXIMAL TIBIA. THE PATIENT REPORTEDLY JUMPED THE POST WHICH LED TO THE DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 20615643 ↗
• InjurySep 10, 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 56-YEAR-OLD MALE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT AND PROXIMAL TIBIAL REPLACEMENT UNDERWENT A REVISION ON (B)(6) 2024 DUE TO DISLOCATION OF THE POLY SPACER AND ROTATIONAL HINGE FROM THE PROXIMAL TIBIA; THE POLY SPACER WAS SAID TO HAVE SNAPPED WHEN THE DISLOCATION HAPPENED. THE PATIENT IS ALSO AFFECTED BY AN ALLEGED CHRONIC INFECTION.

  Patient problems: Joint Dislocation; Medical device site infection

  MAUDE report 20180885 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY P. MEDINA, AN ONKOS SALES REPRESENTATIVE, THAT A 70-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR & PROXIMAL TIBIA REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE SURGEON, DOCTOR MAALE, WASHED OUT THE OPERATIVE JOINT AND REPLACED THE ELEOS DEVICES.

  Patient problems: Medical device site infection

  MAUDE report 19671989 ↗
• InjuryAug 23, 2023Adverse 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 WITH AN ELEOS PROXIMAL TIBIA REPLACEMENT SYSTEM IS INFECTED. THE PATIENT WILL BE UNDERGOING A REVISION SURGERY, HOWEVER, IT HAS NOT YET BEEN SCHEDULED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 17603771 ↗
• InjuryAug 17, 2023Adverse 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 UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: TIBIAL HINGE COMPONENT, RESURFACING FEMUR AXIAL PIN, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S ORIGINAL PROCEDURE: STEM EXTENSION, SEGMENTAL STEM, RESURFACING FEMUR, AND PROXIMAL TIBIA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 17566116 ↗
• InjuryJan 27, 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. THE PATIENT UNDERWENT A REVISION SURGERY ON 31 DECEMBER 2022 WHERE THE SURGEON REVISED THE FOLLOWING ELEOS IMPLANTS: RESURFACING FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, AND POLY SPACER. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE PATIENT'S INDEX PROCEDURE: PROXIMAL TIBIA, SEGMENTAL STEM, RESURFACING FEMUR, AND STEM EXTENSION. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16255679 ↗
• InjuryNov 18, 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 ON (B)(6) 2022 DUE TO AN ALLEGED INFECTION. THE PATIENT'S INDEX SURGERY OCCURED ON (B)(6) 2021 WHERE THE PATIENT WAS IMPLANTED WITH THE FOLLOWING IMPLANTS: ELEOS PROXIMAL TIBIA, ELEOS RESURFACING FEMUR AXIAL PIN, ELEOS POLY SPACER, ELEOS TIBIAL HINGE, ELEOS SEGMENTAL STEM, ELEOS STEM EXTENSION, AND ELEOS RESURFACING FEMUR. DURING THE REVISION PROCEDURE, THE ELEOS PROXIMAL TIBIA, ELEOS RESURFACING FEMUR AXIAL PIN, ELEOS POLY SPACER, AND ELEOS TIBIAL HINGE WERE REMOVED AND REPLACED. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY, AS THE PATIENT UNDERWENT A REVISION PROCEDURE. ALL THE DEVICES IMPLANTED AT THE TIME OF INFECTION WILL BE REPORTED. THIS REPORT CAPTURES THE ELEOS PROXIMAL TIBIA.

  Patient problems: Unspecified Infection

  MAUDE report 15826359 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO AN ALLEGED INFECTION. THE PATIENT WAS INITIALLY IMPLANTED ON 08 SEPTEMBER 2022 WITH THE FOLLOWING ELEOS IMPLANTS: STEM EXTENSION, RESURFACING AXIAL PIN, STRAIGHT CEMENTED STEM, RESURFACING FEMUR, PROXIMAL TIBIA, TIBIAL HINGE W/ ROTATIONAL STOP, RESURFACING FEMUR TAPERED SCREW, AND A POLY SPACER. ON 04 OCTOBER 2022 THE PATIENT WAS REVISED TO REMOVE AND REPLACE THE AXIAL PIN, TIBIAL HINGE, AND POLY SPACER. THE REMAINING DEVICES WERE LEFT IMPLANTED IN THE PATIENT. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO REVISION PROCEDURE. ALL DEVICES WHICH WERE IMPLANTED AT THE TIME OF THE ALLEGED INFECTION WILL BE REPORTED. THIS RECORD CAPTURES THE ELEOS PROXIMAL TIBIA.

  Patient problems: Unspecified Infection

  MAUDE report 15711929 ↗
• 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 14649397 ↗
• InjuryMar 21, 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 ON (B)(6) 2022 DUE TO SUTURE TEARING POST-OPERATIVELY. THE TIBIAL TUBERCLE WAS NO LONGER ATTACHED TO THE ELEOS PROXIMAL TIBIA IMPLANT, CAUSING THE PATIENT TO EXPERIENCE ANTERIOR KNEE PAIN. DURING THE REVISION PROCEDURE, THE ELEOS TIBIAL POLYSPACER, ELEOS TIBIAL HINGE, ELEOS RESURFACING FEMUR AXIAL PIN, AND ELEOS PROXIMAL TIBIA WERE REPLACED. NO SPECIFIC DEVICE FAILURES RELATED TO AN ONKOS IMPLANT WERE REPORTED. HOWEVER, THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO REVISION PROCEDURE. THIS RECORD CAPTURES THE ELEOS PROXIMAL TIBIA.

  Patient problems: Pain

  MAUDE report 13840377 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(4) 2022 FOR AN ALLEGED INFECTION. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE EXPLANTED: ELEOS PROXIMAL TIBIA 87MM, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS TIBIAL POLY SPACER 8MM, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. DURING THIS REVISION SURGERY THE FOLLOWING IMPLANTS WERE IMPLANTED: ELEOS PROXIMAL TIBIA 87MM, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS TIBIAL POLY SPACER 8MM, AND ELEOS TIBIAL HINGE COMPONENT W/ ROTATIONAL STOP. AFTER THIS REVISION SURGERY THE FOLLOWING IMPLANTS REMAIN IMPLANTED: ELEOS RESURFACING FEMUR AXIAL PIN SIZE 2. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13586307 ↗
• MalfunctionFeb 3, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT SUTURES TORE INTRAOPERATIVELY ON THE ANTERIOR/POSTERIOR HOLES OF AN ELEOS PROXIMAL TIBIA. DR. (B)(6) WAS USING ETHIBOND 5 SUTURES. THE SURGEON BROUGHT THE SUTURES ANTERIORLY AFTER EXITING THE POSTERIOR SUTURE HOLES, WHICH RESULTED IN THE SUTURES TEARING. IN ORDER TO SUCCESSFULLY COMPLETE THE SURGERY, DR. (B)(6) DOUBLED UP ON THE SUTURES. NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 13443189 ↗
• InjuryDec 29, 2021Adverse 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 AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, ALL OF THE ELEOS IMPLANTS WERE EXPLANTED AND A STRYKER INTERCALARY SYSTEM WAS PLACED. THE FOLLOWING ELEOS IMPLANTS WERE EXPLANTED ON (B)(6) 2021: PROXIMAL TIBIA, POLY SPACER, TIBIAL HINGE COMPONENT, CANAL-FILLING STEM EXTENSION, RESURFACING FEMUR AXIAL PIN, SEGMENTAL STEM, RESURFACING FEMUR, AND RESURFACING PATELLA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13115767 ↗
• InjuryNov 6, 2021Adverse 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 AND UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. DURING THE REVISION SURGERY, THE FOLLOWING ELEOS IMPLANTS WERE REVISED: RESURFACING FEMUR AXIAL PIN, POLY SPACER, AND TIBIAL HINGE COMPONENT. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY: CEMENTED STEM EXTENSION, BIOGRIP COLLAR, COLLAR LOCKING RING, RESURFACING FEMUR, CEMENTED STEM, AND PROXIMAL TIBIA. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12755838 ↗
• MalfunctionMar 11, 2021Sharp Edges; Sharp Edges

  A PATIENT UNDERWENT A SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6) DUE TO AN INTRAOPERATIVE ISSUE INVOLVING SUTURES RUPTURING WHEN BEING TIGHTENED IN THE ANTERIOR POSTERIOR SUTURE HOLES OF THE BIOGRIP PROXIMAL TIBIA. THE SURGEON USED SIZE 2 AND 5 ETHIBOND SUTURES TO FIXATE SOFT TISSUE WHEN PLACING A GASTROCNEMIUS MUSCLE FLAP OVER THE IMPLANT. THE SUTURES RUPTURED. THE SURGEON SWITCHED TO FIBERWIRE WHICH FRAYED BUT HELD THE SOFT TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11462054 ↗
• MalfunctionMar 1, 2021Sharp Edges; Sharp Edges

  A PATIENT UNDERWENT A SURGERY ON (B)(6) 2021 PERFORMED BY DR. FABBRI TO PLACE ELEOS COMPONENTS FOR A PATIENT WHO HAD THE PROXIMAL END OF HIS TIBIA RESECTED. A PROXIMAL TIBIA IMPLANT WAS PLACED DURING THE SURGERY. WHEN THE SURGEON ATTEMPTED TO PLACE SUTURES THROUGH THE SUTURE HOLES OF THE IMPLANT FOR FIXATION OF SOFT TISSUE, THE EDGES OF THE SUTURE HOLES OF THE IMPLANT WERE CAUSING THE SUTURES TO RUPTURE WHEN THE SURGEON TIGHTENED THEM TO TIE THE ENDS TOGETHER. THE SURGEON FIRST USED A ETHIBOND 5/0 SUTURE, BUT THEY RUPTURED. THE SURGEON THEN SWITCHED TO A ETHIBOND 1 SUTURE, BUT THEY ALSO RUPTURED. THE SURGEON WRAPPED THE SUTURES AROUND AND TIED THE ENDS TOGETHER ON THE POSTERIOR SIDE OF THE IMPLANT. THIS ALLOWED FOR THE SUTURES TO NOT BE PULLED BACK AGAINST THE SHARP EDGE OF THE SUTURE HOLES ON THE IMPLANT. THE SALES REPRESENTATIVE STATED THAT THE SUTURES RUPTURING ADDED APPROXIMATELY 20 MINUTES TO THE SURGERY TIME. HE ALSO STATED THAT THE SURGEON DETERMINED THAT TYING THE SUTURES BEHIND THE IMPLANT WOULD BE SUFFICIENT FOR THE PATIENT AND THAT NO REVISION SURGERY WOULD BE REQUIRED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 11396800 ↗