GENESIS II 71420134Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010430144), received between Sep 20, 2017 and Mar 10, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CHRONIC INFECTION IT WAS DECIDED TO EXPLANTED THE IMPLANTS, GII OXINIUM FEM SIZE 4 LEFT, GNS II CMT TIB SIZE 5 LEFT AND LGN XLPE DISHED ISRT SZ 5-6 9MM. SITE WAS WASHED OUT. ONCE WOUND WAS OPENED SAMPLES WERE TAKEN AND SENT TO HISTOLOGY. A COCR GENII FEMUR AND ALL POLY TIBIA WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11449977 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY SURGERY OF THE RIGHT KNEE ON (B)(6) 2007 AND THE LEFT KNEE ON (B)(6) 2007. IT WAS REPORTED A FROZEN KNEES ISSUE. ON 2010 THE PATIENT RECEIVED A KNEE MANIPULATION THAT WAS UNSUCCESSFUL. NO ADDITIONAL INFORMATION ABOUT THIS EVENT WAS PROVIDED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 10818246 ↗
• InjuryOct 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT A PRIMARY TKA WAS PERFORMED ON (B)(6) 2013. ON (B)(6) 2019 THE FEMORAL COMPONENT WAS BROKEN. AND A REVISION SURGERY WAS REQUIRED TO REMOVED THE BROKEN DEVICE. IMPLANTS WERE REMOVED ON (B)(6) 2019. THE PATIENT HAS RECOVERED.

  Patient problems: Injury

  MAUDE report 9209793 ↗
• InjuryOct 3, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE WEAR AND METAL DEBRIS NOTED ON X-RAYS.

  Patient problems: Injury; Radiation Exposure, Unintended

  MAUDE report 7931895 ↗
• InjurySep 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 7921268 ↗
• InjurySep 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6881066 ↗

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, Classified
  smith&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, Classified
  smith&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