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ELEOS™ PF-2000L-02MRecalls & reported problems

Onkos Surgical, Inc. · ELEOS™ SEGMENTAL PROXIMAL FEMUR, PLASMA SPRAY, 98MM RESECTION, LEFT, 135 DEG · Class 2 · Implant

Quick summary

This Onkos Eleos proximal femur replacement is an implanted hip prosthesis used to replace part of the thigh bone. The 25 reports that name its identifier mostly describe infections around the implant that led to repeat surgery to wash out or swap components, with a few mentioning joint dislocation. The reports mention 25 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
25
Deaths reported
0
Injuries reported
25
Recalls naming it
0

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI B278PF2000L02M0), received between Apr 1, 2021 and Apr 23, 2026 — classified as 25 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 4 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 2 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 3 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem24
  • Insufficient Device Problem Information1

Patient problems

  • Unspecified Infection11
  • Medical device site infection9
  • Joint Dislocation3
  • Fall2
  • Insufficient Information2
  • Implant Pain1
  • Limb Pain1
  • Scar Tissue1

Recent adverse event reports

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

  • InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Unspecified Infection

    MAUDE report 24967097 ↗
  • InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. SURGEON PERFORMED I&D WITH MODULAR COMPONENT SWAP. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Medical device site infection

    MAUDE report 24626286 ↗
  • InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 65-YEAR-OLD FEMALE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Medical device site infection

    MAUDE report 24394820 ↗
  • InjuryDec 23, 2025Adverse 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 65-YEAR-OLD FEMALE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT UNDERWENT REVISION DUE TO AN ALLEGED INFECTION. ALL COMPONENTS BUT THE TIBIAL BASEPLATE AND TIBIAL STEM WERE SWAPPED. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Unspecified Infection

    MAUDE report 23881915 ↗
  • InjuryDec 8, 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 PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. WASHOUT AND SWAPPED COMPONENTS. THERE IS UNKNOWN INFORMATION ABOUT THE REVISION SURGERY, BUT AN MDR WILL BE REPORTED ON THE DEVICES EXPLANTED. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Insufficient Information; Unspecified Infection

    MAUDE report 23745486 ↗
  • InjuryDec 8, 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 FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Unspecified Infection

    MAUDE report 23742971 ↗
  • InjuryNov 28, 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 PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Unspecified Infection

    MAUDE report 23673909 ↗
  • InjurySep 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 72-YEAR-OLD FEMALE PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES THE ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Unspecified Infection

    MAUDE report 23030128 ↗
  • InjurySep 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 56-YEAR-OLD FEMALE PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO A THIGH PAIN. IT WAS REPORTED THAT THE STEM WAS NOT LOOSE AND ONLY THE PROXIMAL FEMUR WAS SWAPPED FOR REVISION. THIS REPORT CAPTURES THE ELEOS PROXIMAL FEMUR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Patient problems: Implant Pain; Limb Pain

    MAUDE report 23028468 ↗
  • InjuryFeb 25, 2025Adverse 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 72-YEAR-OLD MALE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO THE DISLOCATION OF THE IMPLANTED ELEOS FEMORAL HEAD FROM A NON-ONKOS BIPOLAR ACETABULAR LINER.

    Patient problems: Joint Dislocation

    MAUDE report 21464218 ↗
  • InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY PATRICK MEDINA, AN ONKOS SALES REPRESENTATIVE, THAT A 68-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY TO A DISASSOCIATION OF THE ELEOS PROXIMAL FEMUR FROM THE REMAINING NON-ONKOS FEMORAL HEAD AND ACETABULAR DEVICES IN THE PATIENT'S HIP. THE ROOT CAUSE OF THE INCIDENT WAS REPORTEDLY DUE TO THE NON-ONKOS FEMORAL HEAD BECOMING STUCK TO THE NON-ONKOS ACETABULAR LINER WHICH ULTIMATELY CAUSED THE CONSTRUCT TO DISASSOCIATE FROM THE ELEOS PROXIMAL FEMUR.

    Patient problems: Joint Dislocation

    MAUDE report 21019597 ↗
  • InjuryJul 22, 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 AN 82-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT A REVISION ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION. DOCTOR (B)(6) REPORTEDLY REMOVED ALL EXISTING ONKOS HARDWARE FROM THE PATIENT.

    Patient problems: Medical device site infection

    MAUDE report 19800156 ↗
  • InjuryJul 8, 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 72-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE ELEOS PROXIMAL FEMUR AND NON-ONKOS FEMORAL HEAD WERE REPLACED DURING THE PROCEDURE PERFORMED BY DOCTOR (B)(6).

    Patient problems: Medical device site infection

    MAUDE report 19696685 ↗
  • InjuryJun 26, 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 60-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT A REVISION ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION.

    Patient problems: Medical device site infection

    MAUDE report 19616476 ↗
  • InjuryJun 17, 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 82-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT A REVISION ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION.

    Patient problems: Medical device site infection

    MAUDE report 19553813 ↗
  • InjuryJun 17, 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 82-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT A REVISION ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION.

    Patient problems: Medical device site infection

    MAUDE report 19551010 ↗
  • InjuryJun 8, 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 72-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION ON (B)(6) 2024. THE PROXIMAL FEMUR AND FEMORAL HEAD WERE REPLACED DURING THE PROCEDURE PERFORMED BY DOCTOR ABBASCHIAN.

    Patient problems: Medical device site infection

    MAUDE report 19493427 ↗
  • InjuryMar 27, 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 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 18989336 ↗
  • 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 17704042 ↗
  • InjuryJul 5, 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 (B)(6) 2023 WHERE THE FOLLOWING ELEOS IMPLANT WAS REVISED: FEMORAL HEAD. A DIFFERENT COMPANY'S BIPOLAR SHELL IMPLANT WAS ALSO REVISED DURING THIS PROCEDURE. THE FOLLOWING ELEOS IMPLANTS REMAIN IMPLANTED: PROXIMAL FEMUR, SEGMENTAL STEM, BIOGRIP COLLAR, AND COLLAR LOCKING RING. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 17258788 ↗
  • InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2022 IT WAS REPORTED THAT THE PATIENT HAD AN ALLEGED FALL THAT CONTRIBUTED TO AN ALLEGED INFECTION THEY PRESENTED WITH AFTER RECEIVING TOTAL FEMORAL REPLACEMENT SURGERY ON (B)(6) 2021. THE IMPLANTING SURGEON PERFORMED A DISTAL FEMUR REVISION SURGERY ON (B)(6) 2022 AND THE FOLLOWING IMPLANTS WERE REVISED: ELEOS TIBIAL HINGE COMPONENT W/O ROTATIONAL STOP, ELEOS TIBIAL BASEPLATE SIZE 3, ELEOS DISTAL FEMUR AXIAL PIN, ELEOS TIBIAL POLY SPACER 8MM AND ELEOS DISTAL FEMUR. THE FOLLOWING IMPLANTS REMAIN IMPLANTED IN THE PATIENT: ELEOS STEM EXTENSION CEMENTED 12MM X100MM STRAIGHT FLUTED, ELEOS MALE-FEMALE MIDSECTION 50MM, ELEOS MALE-FEMALE MIDSECTION 40MM, ELEOS MALE-FEMALE MIDSECTION 40MM, ELEOS PROXIMAL FEMUR 98MM LEFT 135 DEG, AND ELEOS MALE-MALE MIDSECTION 40MM. IT WAS REPORTED THAT THE SURGEON PLANS TO HAVE ONE MORE REVISION SURGERY WHEN THE INFECTION CLEARS UP. NO REVISION SURGERY HAS BEEN SCHEDULED YET. NO ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN PROVIDED.

    Patient problems: Fall; Insufficient Information; Unspecified Infection

    MAUDE report 13500635 ↗
  • InjuryAug 4, 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 HAD FALLEN AND IT CAUSED AN OPEN SORE ON THEIR LEFT HIP. THE PATIENT LAID WITH AN OPEN WOUND FOR APPROXIMATELY TWO WEEKS. DURING THE REVISION SURGERY, THE SURGEON PERFORMED HEAVY INCISION AND DRAINAGE AND PERFORMED A BIPOLAR EXCHANGE FOR INFECTION CONTROL. THE FOLLOWING IMPLANTS REMAIN IMPLANTED FROM THE ORIGINAL SURGERY ON (B)(6) 2020: ELEOS PROXIMAL FEMUR (98MM), ELEOS MALE-FEMALE MIDSECTION (110MM), ELEOS MALE-FEMALE MIDSECTION (70MM), AND ELEOS CEMENTED STEM (15X120MM). THE FOLLOWING IMPLANTS WERE REVISED DURING THE REVISION SURGERY: ELEOS FEMORAL HEAD (36MM, +0MM TAPER) AND A MICROPORT GLADIATOR BIPOLAR SHELL (56MM). NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED.

    Patient problems: Fall; Unspecified Infection

    MAUDE report 12273490 ↗
  • InjuryJun 3, 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 DUE TO AN ALLEGED INFECTION. THE FOLLOWING PARTS WERE REMOVED AND REVISED: DISTAL FEMUR AXIAL PIN, TIBIAL HINGE COMPONENT, TIBIAL POLY SPACER. THE FOLLOWING PARTS REMAIN IMPLANTED FROM THE ORGIINAL ELEOS SURGERY WHICH TOOK PLACE ON (B)(6) 2021: DISTAL FEMUR, FEMORAL HEAD, STEM EXTENSION, 140MM MALE-FEMALE MIDSECTION, 50MM MALE-FEMALE MIDSECTION, RESURFACING PATELLA, 50MM MALE-MALE MIDSECITON, TIBIAL BASEPLATE. AND A PROXIMAL FEMUR. THE SURGEON REMOVED IMPLANTS WITH POLY COMOPENTS AND PERFORMED A WASHOUT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

    Patient problems: Unspecified Infection

    MAUDE report 11935729 ↗
  • InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem

    A (B)(6) -YEAR-OLD FEMALE PATIENT WAS EXPERIENCING PAIN IN HER HIP AFTER MULTIPLE REVISION SURGERIES HAD BEEN PERFORMED OVER THE PAST YEAR. THIS ISSUE STARTED ON (B)(6) 2021. SCAR TISSUE HAD DEVELOPED IN THE SOFT TISSUE CAVITY FROM THE PREVIOUS SURGERIES. THE SURGEON, DR. (B)(6), DECIDED THAT THE PATIENT'S SEGMENTS SHOULD BE SHORTENED TO RELIEVE THE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHERE A 60MM MALE-FEMALE MIDSECTION WAS REMOVED AND REPLACED WITH A 40MM MALE-FEMALE MIDSECTION AND A 50MM MALE-MALE MIDSECTION WAS REMOVED AND REPLACED WITH A 40MM MALE-MALE MIDSECTION. THE PRIMARY ELEOS SURGERY, WHICH WAS PERFORMED FOR UNKNOWN REASONS, WAS PERFORMED ON (B)(6) 2020 TO PLACE A TOTAL FEMUR SYSTEM. THE PATIENT HAD A PROXIMAL FEMUR IMPLANT AND A MALE-FEMALE MIDSECTION REVISED DURING HER PREVIOUS REVISION SURGERY WHICH OCCURRED ON (B)(6) 2020. DURING THE REVISION ON (B)(6) 2021, A 50MM MALE-MALE MIDSECTION WAS REPLACED WITH A 40MM MALE-FEMALE MIDSECTION. A 40MM MALE-FEMALE MIDSECTION AND A PROXIMAL FEMUR WERE REPLACED WITH THE SAME SIZED IMPLANTS. A 60MM MALE-FEMALE MIDSECTION WAS PRESENT DURING THE REVISION BUT WAS NOT REVISED. IT IS BELIEVED THAT THE PATIENT HAS A MICR

    Patient problems: Scar Tissue

    MAUDE report 11624582 ↗
  • InjuryApr 1, 2021Insufficient Device Problem Information

    A 72-YEAR-OLD FEMALE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 PERFORMED BY DR. (B)(6) DUE TO THE PATIENT'S HIP DISLOCATING. THE PATIENT HAD A PROXIMAL FEMUR IMPLANT AND A MALE-FEMALE MIDSECTION PLACED DURING HER PREVIOUS REVISION SURGERY WHICH OCCURRED ON (B)(6) 2020. DURING THE REVISION ON (B)(6) 2021, THE SURGEON REPLACED THE MALE-FEMALE MIDSECTION AND THE PROXIMAL FEMUR IMPLANT. THE MALE-FEMALE MIDSECTION THAT WAS EXPLANTED WAS 70 MILLIMETERS. THIS WAS REPLACED WITH A 60MM MALE-FEMALE MIDSECTION. THE SALES REPRESENTATIVE STATED THAT THIS WAS DONE IN AN ATTEMPT TO MITIGATE THE RISK OF FUTURE DISLOCATIONS.

    Patient problems: Joint Dislocation

    MAUDE report 11604588 ↗

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-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-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-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-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

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.