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GENESIS II 71430831Recalls & reported problems

Smith & Nephew, Inc. · GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 5-6 11MM · 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 03596010213518), received between Jul 30, 2022 and Jul 30, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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

  • Degraded1
  • Fracture1
  • Naturally Worn1

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.

  • MalfunctionJul 30, 2022Degraded; Fracture; Naturally Worn; Degraded; Fracture; Naturally Worn

    IT WAS REPORTED THAT, A G2 P/S ART TR SZ5-6 11MM WAS NOTICED WITH CHIPPED PLASTIC AND GENERAL WEAR. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15136785 ↗

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Sources and updates

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