GENESIS II 71420156Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010430816), received between Jul 26, 2018 and Feb 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A CHRONIC INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH GII OXINIUM FEM SIZE 7 RIGHT, GEN II RESURF PATELLA 38MM, GNS II NON-POR TIB SZ 7 RIGHT AND LGN CR HIGH FLEX XLPE SZ 7-8 11MM WERE EXPLANTED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 21368033 ↗
• InjuryDec 22, 2023Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT, AFTER RIGHT TKA WAS PERFORMED IN 2022, THE PATIENT NOTED THAT THE FEMUR WOULD SUBLUX FROM THE TIBIA WHEN DOING A SINGLE LEG SQUAT AND THEN ROTATING. THE SURGEON INDICATED THIS WAS A VERY UNUSUAL MOVEMENT, FOR WHICH A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IMPLANTING A LEGION HINGE SYSTEM TO PROVIDE MAXIMUM STABILITY. PATIENT IS CURRENTLY MOBILIZING WELL.

  Patient problems: Subluxation

  MAUDE report 18383599 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 7724623 ↗

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