GENESIS II 71420154Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010430199), received between Feb 27, 2019 and Nov 29, 2022 — classified as 2 injuries.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED STIFFNESS AND QUERY INFECTION, FOR WHICH A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THE FOLLOWING DEVICES WERE EXPLANTED: LGN CR HIGH FLEX XLPE SZ 5-6 10MM, GNS II BICONVEX PAT 26MM, GII OXINIUM FEM SIZE 6 RIGHT AND GNS II CMT TIB SIZE 5 RIGHT. SAMPLES WERE TAKEN INTRAOPERATIVELY THAT DIDN¿T SUGGEST INFECTION. THEY PROCEEDED WITH LEGION REVISION WITH STEMS AND A TIBIAL CONE. PATIENT'S CURRENT HEATH STATUS IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 15882600 ↗
• InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INCREASING PAIN. NO DELAY TO PROCEDURE WAS REPORTED.

  Patient problems: Pain

  MAUDE report 8374340 ↗

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