ELEOS Limb Salvage System With BioGrip PB-3600R-03MRecalls & reported problems
Onkos Surgical, Inc. · MODULAR POROUS BIOGRIP® COLLAR, 36MM, HA COATED · Class 2 · Implant
All models of ELEOS Limb Salvage System With BioGrip (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B278PB3600R03M0), received between May 7, 2025 and Nov 28, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Aseptic loosening1
- Medical device site infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 LOOSENING OF THE SEGMENTAL STEM AND COLLAR. CEMENT DID NOT BOND TO STEM AND NO GROWTH ON COLLAR. THIS REPORT CAPTURES ELEOS HA COLLAR. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.
Patient problems: Aseptic loosening
MAUDE report 23673952 ↗InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ONKOS SALES REPRESENTATIVE REPORTED A REVISION SURGERY WHICH TOOK PLACE ON (B)(6) 2025 DUE TO AN ALLEGED PERIPROSTHETIC JOINT INFECTION IN AN 85-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT.
Patient problems: Medical device site infection
MAUDE report 21979057 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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