GUARDIAN® 25002100Recalls & reported problems
Microport Orthopedics Inc. · GUARDIAN® TIBIAL HINGE BASE W/ ROTATIONAL STOP PIN · Class 2 · Implant
All models of GUARDIAN (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M684250021001), received between Jul 31, 2019 and Dec 15, 2023 — classified as 10 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break3
- Insufficient Device Problem Information3
- Unstable2
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Loss of Osseointegration1
- Use of Device Problem1
Patient problems
- No Information4
- Insufficient Information2
- Loss of Range of Motion2
- Unspecified Infection2
- Bone Fracture(s)1
- Fluid Discharge1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, A GUARDIAN DISTAL FEMUR WAS REVISED ON (B)(6) 2023 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 18336308 ↗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 12292000 ↗InjuryJul 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, THE PATIENT HAD AN EFFUSION THAT WAS DRAINED AND SINCE THEY WERE IN THERE THEY DID AN EXTENSIVE WASHOUT AND CHANGED THE POLY COMPONENTS. SAMPLES WERE SENT BUT THERE WAS NOTHING ACUTE. THE CAUSE OF THE ISSUE IS UNKNOWN.
Patient problems: Fluid Discharge; Insufficient Information
MAUDE report 12132646 ↗InjuryMar 2, 2021Unstable; Unstable
ALLEGEDLY, THERE WAS UNSTABLE CONSTRUCT.
Patient problems: Insufficient Information
MAUDE report 11401603 ↗InjuryOct 9, 2020Break; Break
ALLEGEDLY, PATIENT UNDERWENT A REVISION SURGERY DUE TO THE HINGE COMPONENT FRACTURING. ADDITIONAL INFORMATION RECEIVED ON 09/16/2020 : ADDING PRODUCT INFORMATION.
Patient problems: No Information
MAUDE report 10656239 ↗InjuryJun 26, 2020Loss of Osseointegration; Detachment of Device or Device Component; Loss of Osseointegration; Detachment of Device or Device Component
ALLEGEDLY, PATIENT WAS REVISED DUE TO FEMUR IMPLANT FRACTURED AT THE MORSE TAPER, THE TIBIAL IMPLANT WAS LOOSE, AND THERE WAS A DISSOCIATION OF THE TIBIAL STEM.
Patient problems: No Information
MAUDE report 10201058 ↗InjuryMay 19, 2020Break; Break
ALLEGEDLY, PATIENT UNDERWENT A REVISION SURGERY DUE TO THE TIBIAL HINGE COMPONENT POST FRACTURING.
Patient problems: Bone Fracture(s)
MAUDE report 10071472 ↗MalfunctionMar 31, 2020Use of Device Problem; Use of Device Problem
ALLEGEDLY, PATIENT UNDERWENT A REVISION SURGERY OF THEIR HINGE KNEE SYSTEM. PATIENT HAS A LOT OF CO-MORBIDITIES AND WASN'T MOVING HIS JOINT AND IT STIFFENED UP COMPONENTS NOT REVISED. 25001050, 1557251. 25000007, 1643677.
Patient problems: Loss of Range of Motion
MAUDE report 9906172 ↗InjuryMar 16, 2020Break; Break
ALLEGEDLY, PATIENT'S TIBIAL HINGE COMPONENT FRACTURED , REVISION SURGERY TO REPLACE THE HINGE HAS NOT BEEN SCHEDULED YET. PRODUCTS NOT REVISED : GUARDIAN STEM W/COLLAR PRODUCT ID: 2500CC13, LOT NUMBER: 0301065827. GUARDIAN MID SECTION PRODUCT ID: 25001060, LOT NUMBER: 1612199. GUARDIAN TIBIAL POLY SPACER PRODUCT ID: 25001208, LOT NUMBER: 1644331. GUARDIAN MID SECTION PRODUCT ID: 25001040, LOT NUMBER: 1648004.
Patient problems: No Information
MAUDE report 9835793 ↗InjuryDec 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT HAD A FLEXION CONTRACTURE AND THEY SWAPPED A LONGER MIDSECTION OUT FOR A SHORTER BODY.
Patient problems: Loss of Range of Motion
MAUDE report 9453233 ↗InjuryJul 31, 2019Unstable; Unstable
ALLEGEDLY THE PATIENT WAS REVISED DUE TO INSTABILITY. THE HINGE COMPONENTS WERE IN TWO PIECES-THE STEM SEPARATED FROM THE BASE. DR (B)(6) REVISED THE AXIAL PIN, HINGE COMPONENT, AND 8MM POLY
Patient problems: No Information
MAUDE report 8848820 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
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- 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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