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GENESIS II 71436384Recalls & reported problems

Smith & Nephew, Inc. · GENESIS II PLASTIC REAMTHRU FEMORAL TRIAL SIZE 4 LEFT · Class 2

All models of GENESIS II (462)

Data updated Oct 18, 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 00885556625828), received between Apr 28, 2019 and Apr 28, 2019 — classified as 1 malfunction.

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

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionApr 28, 2019Break; Break

    IT WAS REPORTED THAT DURING A TKR THE DEVICE BROKE WHILE IT WAS BEING IMPACTED. NO BACKUP DEVICE AVAILABLE. NO INJURIES, A DELAY FROM 0-30 MINUTES WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8559678 ↗

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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