GENESIS II 71430492Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II CRUCIATE RETAINING ARTICULAR TRIAL SIZE 3-4 11MM · Class 1
All models of GENESIS II (462)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010212122), received between Aug 20, 2020 and Dec 26, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Flaked1
- Material Deformation1
- Material Integrity Problem1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2023Flaked; Material Deformation; Flaked; Material Deformation
IT WAS REPORTED THAT, DURING TKA SURGERY, A G2 C/R ART TR SZ3-4 11MM WAS NOTICED TO HAVE FLAKING AND INDENTATION WHEN INSERTING/EXTRACTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18395153 ↗MalfunctionAug 21, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE G2 C/R ART TRIAL SZ3-4 11MM IS VERY WORN, CHIPPED, AND/OR CRACKED. AS THIS WAS NOTICED UPON OFFICE INSPECTION, NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10440385 ↗MalfunctionAug 20, 2020Break; Break
IT WAS REPORTED THAT, DURING OFFICE INSPECTION PROCESS, THE G2 C/R ART TR SZ3-4 11MM INSERT WAS FOUND CHIPPED AND/OR DAMAGED. THERE WAS NO CASE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10431153 ↗
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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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