GENESIS II 71420150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010430175), received between Dec 19, 2017 and Dec 27, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ASPIRATION WAS PERFORMED FOR CELL COUNT DUE TO PAIN.

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 8200161 ↗
• InjuryDec 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN ASPIRATION PERFORMED FOR (B)(6) STUDY DUE TO PAIN.

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 8190034 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DOCTOR SENT ESR AND CRP EXAMS, PATIENT HAS TAKEN PERCOCET FOR PAIN MANAGEMENT, X-RAYS WERE PERFORMED, A CORTISONE INJECTION AND A MANIPULATION UNDER ANESTHESIA PROCESS WERE DONE.

  Patient problems: Injury; Radiation Exposure, Unintended

  MAUDE report 7931910 ↗
• InjurySep 30, 2018Unintended Movement; Unintended Movement

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

  Patient problems: Fibrosis; Injury

  MAUDE report 7921374 ↗
• InjuryDec 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO POSTERIOR CRUCIATE LIGAMENT INJURY. THE SURGEON CONSIDERED IT IS NOT THE PRODUCT FAILURE.

  Patient problems: Injury

  MAUDE report 7128118 ↗

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