GENESIS II 71430445Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II CRUCIATE RETAINING DEEP FLEXION INSERT TRIAL SIZE 3-4 11M · 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 03596010512543), received between Feb 2, 2021 and Nov 5, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack3
- Fracture1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, THE GII CR DEEP FLX ISR TR S3-4 11 BROKE WHILE TRAILING. ALL PIECES WERE RECOVERED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20611245 ↗MalfunctionJan 10, 2022Crack; Crack
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII CR DEEP FLX ISR TR S3-4 11 CRACKED. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13214273 ↗MalfunctionDec 6, 2021Crack; Crack
IT WAS REPORTED THAT THE GII CR DEEP FLX ISR TR S3-4 11 WAS CRACKED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12941416 ↗MalfunctionFeb 2, 2021Crack; Naturally Worn; Crack; Naturally Worn
IT WAS REPORTED THAT THE POLYS WERE OLD, WORN, AND STARTING TO CRACK. NO PATIENT INVOLVED IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11268665 ↗
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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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