GUARDIAN® 25002111Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M684250021111), received between Jul 31, 2019 and Dec 14, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 12132648 ↗
• InjuryMar 2, 2021Unstable; Unstable

  ALLEGEDLY, THERE WAS UNSTABLE CONSTRUCT.

  Patient problems: Insufficient Information

  MAUDE report 11401252 ↗
• 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 9906531 ↗
• 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 9453260 ↗
• InjuryJul 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO INFECTION. NO PRODUCTS AFFECTED. EXCHANGED TWO IMPLANTS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8848825 ↗