GENESIS II 71433458Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 7-8 12MM · Class 1
All models of GENESIS II (462)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556480571), received between Nov 10, 2020 and Jun 12, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Flaked” (3 reports).
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
- Flaked3
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2022Flaked; Flaked
IT WAS REPORTED THAT GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIALS FROM SIZE 1-2 10MM TO SIZE 7-8 12MM ARE STARTING TO FLAKE AND CHIP. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14671984 ↗MalfunctionJun 11, 2022Flaked; Flaked
IT WAS REPORTED THAT GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIALS FROM SIZE 1-2 10MM TO SIZE 7-8 12MM ARE STARTING TO FLAKE AND CHIP. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14671951 ↗MalfunctionJun 11, 2022Flaked; Flaked
IT WAS REPORTED THAT GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIALS FROM SIZE 1-2 10MM TO SIZE 7-8 12MM ARE STARTING TO FLAKE AND CHIP. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14671811 ↗MalfunctionNov 10, 2020Crack; Crack
IT WAS REPORTED THAT THE DEVICE HAS A CRACK. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10814843 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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