GENESIS II 71420140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010434661), received between Dec 5, 2024 and Dec 5, 2024 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT STARTED DEVELOPING ANTERIOR KNEE PAIN. THIS ADVERSE EVENT WAS TREATED BY RESURFACING THE PATELLA ON (B)(6) 2024. THERE WAS NO EXPLANTATION OF ONE (1) JOURN ART INS BCS STD 3-4 LT 9, ONE (1) GII OXONIUM FEM SIZE 7 LEFT, ONE (1) GII C/R ART INS SZ 7-8 9MM, ONE (1) GNS II CMT TIB SIZE 7 LEFT AND ONE (1) JOURN ART INS BCS STD 3-4 RT 9 SINCE JUST THE PATELLA WAS RESURFACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 20854032 ↗

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