GENESIS II 71420138Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II OXINIUM FEMORAL SIZE 6 LEFT · Class 2 · Implant
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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010430168), received between Oct 1, 2018 and Dec 12, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K021673, K962557); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Insufficient Device Problem Information1
Patient problems
- Injury2
- Medical device site infection1
- Muscular Rigidity1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER UNDERGOING A TKA EIGHTEEN YEARS AGO, THE PATIENT EXPERIENCED INFECTION AND LOOSENING. THIS ADVERSE EVENT WAS ADDRESSED ON (B)(6)2024, DURING WHICH, ALL IMPLANTS WERE REMOVED (FEMUR, TIBIA BASE, INSERT AND PATELLA). DURING SURGERY, IT WAS FOUND THAT THE INSERT IMPLANTED EIGHTEEN YEARS AGO WAS DEFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 20919423 ↗InjuryJan 31, 2019Break; Break
IT WAS REPORTED THAT THE ANTERIOR FLANGE BROKE OFF IN PATIENT. NO ADDITIONAL INFORMATION SPECIFIED.
Patient problems: Injury
MAUDE report 8293375 ↗InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO STIFFNESS.
Patient problems: Injury; Muscular Rigidity
MAUDE report 7924591 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021673, K962557. One submission often covers many models, so check the product and lot details in each record.
- Z-0281-2025 · Oct 2, 2024 · Open, Classifiedsmith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
- Z-1901-2024 · Apr 24, 2024 · Open, Classifiedsmith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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.
How reports and recalls are matched · Editorial policy · Report an error on this page