Skip to content

GENESIS II 71420370Recalls & reported problems

Smith & Nephew, Inc. · GENESIS II POSTERIOR STABILIZED ALL POLYETHYLENE TIBIAL SIZE3 11MM LEFT · Class 2 · Implant

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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010207289), received between Jun 26, 2018 and Jun 26, 2018 — classified as 1 injury.

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

  • Appropriate Device Problem Term/Code Not Available1

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.

  • InjuryJun 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT PATIENT HAD REVISION SURGERY, ALL POLY TIBIA WAS LOOSE AND REVISED WITH A LEGION REVISION TIBIAL BASEPLATE, OFFSET COUPLER, STEM AND PSHF POLY.

    Patient problems: Injury

    MAUDE report 7636785 ↗

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

How reports and recalls are matched · Editorial policy · Report an error on this page