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GENESIS II 71430441Recalls & reported problems

Smith & Nephew, Inc. · GENESIS II OVAL RESURFACING PATELLAR TRIAL 41MM · Class 2

All models of GENESIS II (462)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010484956), received between Jan 10, 2022 and Feb 15, 2022 — classified as 2 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 18, 2026.

Most reported problems

Device problems

  • Break1
  • Crack1
  • Naturally Worn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 15, 2022Break; Naturally Worn; Break; Naturally Worn

    IT WAS REPORTED THAT A GENESIS II OVAL RESURFACING PATELLAR TRIAL 41MM IS BROKEN DUE TO WEAR AND TEAR. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13537444 ↗
  • MalfunctionJan 10, 2022Crack; Crack

    IT WAS REPORTED THAT A GII OVAL RESURF PAT TRIAL 41MM CRACKED. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13214198 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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