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GENESIS II 71422066Recalls & reported problems

Smith & Nephew, Inc. · GENESIS II HYDROXYAPATITE POROUS TIBIAL BASEPLATE SIZE 4 RIGHT · Class 2 · Implant

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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010496355), received between Mar 20, 2019 and Mar 20, 2019 — classified as 1 injury.

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

  • Injury1

Recent adverse event reports

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

  • InjuryMar 20, 2019Break; Break

    IT WAS REPORTED A FAILURE OF THE TIBIAL COMPONENT. NO INJURIES REPORTED. NO MORE INFORMATION AVAILABLE.

    Patient problems: Injury

    MAUDE report 8438598 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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