GENESIS II 71420146Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010439413), received between Feb 16, 2021 and Mar 3, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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.

• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT HAD A TOTAL KNEE REPLACEMENT 3 YEAR AGO. PATIENT SUFFERED FROM A STIFF KNEE AND LIMITED RANGE OF MOTION 20 DEGREE - 90 DEGREE AND OVERSTUFFED PATELLA FEMORAL JOINT, THEREFORE PATIENT HAD A REVISION SURGERY, WHERE SURGEON REMOVED THE PATELLA, FEMORAL, TIBIAL INSERT AND TIBIAL BASEPLATE FROM PRIMARY SURGERY. SURGEON NOTICED THE PATELLA WAS NOT RESECTED ENOUGH, WHICH CAUSE OVER STUFFING. SURGEON ACHIEVED A RANGE OF MOTION FROM 0 DEGREES - 120 DEGREES RANGE OF MOTION. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 11408614 ↗
• MalfunctionFeb 16, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE GENESIS II OXINIUM FEM SIZE 2 RIGHT WAS NOT LOCKING PROPERLY AND WHILE REMOVING THE INSERT THE FEMUR WAS SCRATCHED. IT WAS REPORTED THAT THERE WAS A SIGNIFICANT DELAY IN THE SURGERY. THE PATIENT WAS INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330954 ↗

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