GUARDIANRecalls & reported problems across all models
Microport Orthopedics Inc. · 22 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls
- 0
We found 22 models of GUARDIAN by Microport Orthopedics Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2018 and Dec 15, 2023 — classified as 42 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GUARDIAN problems
Device problems
- Insufficient Device Problem Information16
- Appropriate Device Problem Term/Code Not Available7
- Unstable7
- Break5
- Adverse Event Without Identified Device or Use Problem4
- Use of Device Problem4
- Loss of Osseointegration2
- Detachment of Device or Device Component1
Patient problems
- Unspecified Infection11
- Insufficient Information9
- Loss of Range of Motion8
- No Information8
- Pain6
- Fluid Discharge3
- Bone Fracture(s)2
- Joint Dislocation1
GUARDIAN models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GUARDIAN® 25002100Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented11 reports
- GUARDIAN® 25001208Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer8 reports
- GUARDIAN® 25002111Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer7 reports
- GUARDIAN® 25002114Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- GUARDIAN® 2500CC13Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- GUARDIAN® 25000007Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- GUARDIAN® 25000009Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GUARDIAN® 25000011Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GUARDIAN® 25001040Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GUARDIAN® 25001060Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GUARDIAN® 25001210Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- GUARDIAN® 25001212Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GUARDIAN® 25001220Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GUARDIAN® 25002101Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GUARDIAN® 25002110Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- GUARDIAN® 25002112Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- GUARDIAN® 25002203Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GUARDIAN® 25004013Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- GUARDIAN® 2500BP16Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- GUARDIAN® 2500L002Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 report
- GUARDIAN® 2500R002Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- GUARDIAN® 2500R004Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
Recent GUARDIAN adverse event reports
The 15 most recent reports across all models, 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 18336325 ↗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 ↗InjuryDec 14, 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 18325998 ↗MalfunctionNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, A GUARDIAN DISTAL FEMUR WAS REVISED.
Patient problems: Insufficient Information
MAUDE report 18085406 ↗InjurySep 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, THE PATIENT HAS DEVELOPED AN INFECTION AND WHEN REVIEWING THE POST BILL, IT WAS IDENTIFIED THAT THE PATIENT HAS A GUARDIAN TIBIAL SLEEVE WITH PLUGS IMPLANTED. THE PATIENT ALSO HAS THE FOLLOWING IMPLANTS PLACED THAT ARE ELEOS: POLY SPACER, DISTAL FEMUR, TIBIAL HINGE COMPONENT, DISTAL FEMUR AXIAL PIN, STEM EXTENSION, THREE MALE-FEMALE MIDSECTIONS, PROXIMAL FEMUR, AND MALE-MALE MIDSECTION. THE PATIENT WILL BE UNDERGOING A REVISION SURGERY WHERE ALL IMPLANTED DEVICES WILL BE EXPLANTED AND AN ONKOS MY3D CUSTOM CASE WILL BE IMPLANTED. THIS REVISION SURGERY HAS NOT BEEN SCHEDULED YET.
Patient problems: Unspecified Infection
MAUDE report 17843390 ↗InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, IN THE REVISION ON (B)(6) 2022 DR. (B)(6) REMOVED THE FEMUR, MIDSECTION, STEM, POLY, AND HINGE AND REPLACED IT WITH NEW PARTS BECAUSE THE PATIENT WAS COMPLAINING OF SOME PAIN.
Patient problems: Pain
MAUDE report 14105424 ↗InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, IN THE REVISION ON (B)(6) 2022 DR. (B)(6) REMOVED THE FEMUR, MIDSECTION, STEM, POLY, AND HINGE AND REPLACED IT WITH NEW PARTS BECAUSE THE PATIENT WAS COMPLAINING OF SOME PAIN.
Patient problems: Pain
MAUDE report 14105340 ↗InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, IN THE REVISION ON (B)(6)2022 DR. (B)(6) REMOVED THE FEMUR, MIDSECTION, STEM, POLY, AND HINGE AND REPLACED IT WITH NEW PARTS BECAUSE THE PATIENT WAS COMPLAINING OF SOME PAIN.
Patient problems: Pain
MAUDE report 14105301 ↗InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, IN THE REVISION ON (B)(6)2022 DR. (B)(6) REMOVED THE FEMUR, MIDSECTION, STEM, POLY, AND HINGE AND REPLACED IT WITH NEW PARTS BECAUSE THE PATIENT WAS COMPLAINING OF SOME PAIN.
Patient problems: Pain
MAUDE report 14104855 ↗InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, IN THE REVISION ON (B)(6) 2022 DR. (B)(6) REMOVED THE FEMUR, MIDSECTION, STEM, POLY, AND HINGE AND REPLACED IT WITH NEW PARTS BECAUSE THE PATIENT WAS COMPLAINING OF SOME PAIN.
Patient problems: Pain
MAUDE report 14104374 ↗InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, IN THE REVISION ON (B)(6)2022 DR. (B)(6) REMOVED THE FEMUR, MIDSECTION, STEM, POLY, AND HINGE AND REPLACED IT WITH NEW PARTS BECAUSE THE PATIENT WAS COMPLAINING OF SOME PAIN.
Patient problems: Pain
MAUDE report 14104120 ↗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 ↗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 12292012 ↗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 ↗
Other Microport Orthopedics Inc. products
All Microport Orthopedics Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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