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GENESIS II 71421310Recalls & reported problems

Smith & Nephew, Inc. · REVISION PRESS FIT STEM NONSLOTTED 10MM X 100MM · 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 03596010001993), received between Oct 30, 2019 and Oct 30, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.

    Patient problems: Pain

    MAUDE report 9255844 ↗

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

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Sources and updates

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