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GENESIS II 71422030Recalls & reported problems

Smith & Nephew, Inc. · GENESIS II CRUCIATE RETAINING HYDROXYAPATITE POROUS FEMORAL SIZE 5 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 03596010496232), received between Dec 19, 2022 and Dec 19, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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

  • Failure to Osseointegrate1

Patient problems

  • Failure of Implant1
  • Inadequate Osseointegration1

Recent adverse event reports

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

  • InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate

    IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED IN 2019, A REVISION SURGERY WAS PERFORMED TO CONFIRM GROSS LOOSENING AND NO EVIDENCE OF OSTEOINTEGRATION OF THE GII C/R HA POROUS FEM SZ 5RT DEVICE. CUSTOMER NOTED NO PATIENT FACTORS THAT WOULD HAVE CONTRIBUTED TO THIS. NO FURTHER DETAILS AVAILABLE AT THIS MOMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: Failure of Implant; Inadequate Osseointegration

    MAUDE report 16007702 ↗

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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