GENESIS II 71421118Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010469328), received between Nov 19, 2021 and Sep 12, 2024 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K022010, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA WAS PERFORMED ON (B)(6) 2015, THE PATIENT UNDERWENT AN ARTHROSCOPIC LATERAL RETINACULAR RELEASE ON (B)(6) 2017 DUE TO PAIN. NO FURTHER COMPLICATIONS HAD BEEN REPORTED BY THAT TIME.

  Patient problems: Pain

  MAUDE report 20201238 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAS BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE GII OXIN P/S FEM RIGHT SIZ 8 WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12848209 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022010, 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