GENESIS II 71440003Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II SYMMETRICAL POSTERIOR CONDYLES FIXED POSTERIOR STABILIZED HOUSING COLLET SIZE 2 · Class 1
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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556033906), received between Nov 5, 2020 and Nov 5, 2020 — classified as 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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2020Break; Break
IT WAS REPORTED DURING THE PROCEDURE, WHEN THE SURGEON WENT TO UNSCREW THE SIZE 1-2 LEGION REAMER COLLET, THE SCREW THAT THREADS INTO THE FEMORAL COMPONENT BROKE OFF. THE BROKEN PIECE DID NOT FALL INSIDE THE PATIENT, AND ALL PARTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND BACKUP FROM SMITH & NEPHEW WAS AVAILABLE TO FINISHED THE SURGERY. THERE ARE NO REPORTS/ADVERSE EVENTS TO DOCUMENT WITH THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10795873 ↗
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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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