GENESIS II 71433445Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 5-6 10M · Class 1
All models of GENESIS II (462)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556480076), received between Aug 4, 2021 and Dec 29, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA A GII CR DEEP FLX ISR TR S5-6 10 BROKE AND ALL THE PARTS WERE ACCOUNTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18419471 ↗InjuryAug 4, 2021Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 5-6 10M SPLIT IN HALF WHILE BEING INSERTED INTO THE BASEPLATE. IT REMAINS UNKNOWN HOW THIS PROCEDURE WAS COMPLETED AND WHETHER OR NOT IT CAUSED A SURGICAL DELAY. NO HARM WAS REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12275992 ↗
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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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