GENESIS II 71440850Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II POSTERIOR REFERENCING FEMORAL ALIGNMENT GUIDE · Class 2
All models of GENESIS II (462)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010390394), received between Dec 9, 2020 and Feb 1, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K123598); they may or may not involve this specific model.
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
- Break2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2022Break; Break
IT WAS REPORTED THAT AFTER TKA, THE SPRING MECHANISM INSIDE OF THE GII POST REF FEM ALIGN GDE BROKE. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13416138 ↗MalfunctionApr 28, 2021Break; Break
IT WAS REPORTED THAT, THE CAPTIVE SLOT ENGAGEMENT MECHANISM OF A GENESIS II POST REFLECTION FEM ALIGN GDE IS BROKEN FROM. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11742462 ↗MalfunctionDec 9, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE BOLT/SCREW IS MISSING FROM THE GII POST REF FEM ALIGN GDE. THIS COULD HAPPENED DURING STERILIZATION PROCESS. MALFUNCTION WAS FOUND DURING SET UP/INSPECTION IN TKA PROCEDURE. THERE WAS NO DELAY. A S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10979958 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.
- Z-0730-2019 · Jan 7, 2019 · TerminatedSL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 · Nov 16, 2016 · TerminatedREFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Other Prosthesis, hip, femoral component, cemented, metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
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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