GUARDIAN® 25002114Recalls & reported problems
Microport Orthopedics Inc. · GUARDIAN® RESURFACING FEMUR AXIAL PIN SIZE 4 · Class 2 · Implant
All models of GUARDIAN (22)
Data updated Oct 16, 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 M684250021141), received between Aug 6, 2021 and Mar 2, 2022 — 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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Unspecified Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2022Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, THE SURGEON ELECTED TO DO A WASHOUT AND POLY/HINGE SWAP DUE TO A POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13653419 ↗InjuryAug 6, 2021Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE DUE TO AN INFECTION. COMPONENTS NOT REVISED: RESURFACING FEMUR CATALOG NUMBER: 2500L004, LOT NUMBER: 1744129. CANAL FILLING STEM EXTENSION: CATALOG NUMBER: KSP17140, LOT NUMBER: 0952811091690600. TIBIAL SLEEVE CATALOG NUMBER: 25002205, LOT NUMBER: 0644473001767219. CANAL FILLING STEM EXTENSION CATALOG NUMBER: KSP16100, LOT NUMBER: 15424491757475.
Patient problems: Unspecified Infection
MAUDE report 12292021 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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