GENESIS II 71433452Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556480328), received between Jun 11, 2022 and Jun 11, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Flaked” (3 reports).

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.

• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIALS FROM SIZE 1-2 10MM TO SIZE 7-8 12MM ARE STARTING TO FLAKE AND CHIP. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671962 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIALS FROM SIZE 1-2 10MM TO SIZE 7-8 12MM ARE STARTING TO FLAKE AND CHIP. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671892 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIALS FROM SIZE 1-2 10MM TO SIZE 7-8 12MM ARE STARTING TO FLAKE AND CHIP. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671692 ↗