GUARDIAN® 25001208Recalls & reported problems
Microport Orthopedics Inc. · GUARDIAN® TIBIAL SLEEVE POLY SPACER 8mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M684250012081), received between Mar 31, 2020 and Dec 15, 2023 — classified as 7 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Naturally Worn1
- No Apparent Adverse Event1
- Unstable1
- Use of Device Problem1
Patient problems
- Unspecified Infection3
- Bone Fracture(s)1
- Fluid Discharge1
- Insufficient Information1
- Joint Laxity1
- Loss of Range of Motion1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 8 most recent of 8 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 18336325 ↗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 ↗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 12132647 ↗InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
ALLEGEDLY, THERE WAS A POLY SWAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11410830 ↗InjuryMar 2, 2021Unstable; Unstable
InjuryMay 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT UNDERWENT A REVISION SURGERY DUE TO AN ALLEGED INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10085667 ↗InjuryMay 19, 2020Naturally Worn; Naturally Worn
ALLEGEDLY, PATIENT UNDERWENT A REVISION SURGERY DUE TO THE TIBIAL HINGE COMPONENT POST FRACTURING.
Patient problems: Bone Fracture(s)
MAUDE report 10071575 ↗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 9904417 ↗
Other Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1417United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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