GENESIS II 71430244Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II ARTICULAR INSERT SPACER TRIAL SIZE 5-6 18MM · Class 1
All models of GENESIS II (462)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010211958), received between Nov 5, 2020 and Apr 9, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2021Break; Break
IT WAS REPORTED THAT DURING A CONSIGNMENT INSPECTION THE DEVICE WAS FOUND WITH CORROSION/DISCOLORATION. THE DEVICE WILL BE RETURNED. THE INVESTIGATION FOUND THAT THERE WERE LITTLE PIECES BREAKING OFF IN CERTAIN AREAS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11642651 ↗MalfunctionNov 5, 2020Break; Break
IT WAS REPORTED THAT DURING SURGERY (TKA PROCEDURE), THE GENESIS II INS SPAC TR SIZE 5-6 18MM SNAPPED IN HALF. NOTHING FELL INTO PATIENT AND ALL PIECES WERE RECOVERED. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10791343 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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