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GENESIS II 71422028Recalls & reported problems

Smith & Nephew, Inc. · GENESIS II C/R HA POROUS FEMORAL SZ 4RT · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010496225), received between Oct 12, 2020 and Oct 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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

  • Nonstandard Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionOct 12, 2020Nonstandard Device; Nonstandard Device

    IT WAS REPORTED THAT DURING SURGERY THE SURGEON NOTED THAT THE IMPLANT IS SCRATCHED, AND NOT SUITABLE FOR IMPLANTATION. ANOTHER FEMUR WAS OPENED WHICH WAS NOT SCRATCHED. A DELAY WAS REPORTED THAN, OR EQUAL TO 30 MINUTES. NO IMPACT TO THE PATIENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10663666 ↗

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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