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GENESIS II 71430778Recalls & reported problems

Smith & Nephew, Inc. · GENESIS II DISHED ARTICULAR INSERT TRIAL SIZE 5-6 9MM · Class 1

All models of GENESIS II (462)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010213228), received between Aug 13, 2023 and Aug 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 13, 2023Fracture; Fracture

    IT WAS REPORTED THAT, DURING TKA SURGERY, A G2 DISH ART TR SZ5-6 9MM WAS BROKE IN TWO COMPLETE PIECES WHEN TRIALING, NO PIECES FELL INSIDE THE WOUND. 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 17538077 ↗

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Sources and updates

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