GENESIS II 71433455Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556480472), received between Jul 16, 2020 and Jun 13, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 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 14678231 ↗
• MalfunctionJun 12, 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 14671971 ↗
• 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 14671915 ↗
• MalfunctionNov 9, 2020Crack; Crack

  IT WAS REPORTED THAT DURING EFIP INSPECTION THE GII PS HI FLEX ISRT TR S5-6 10 WAS FOUND CRACKED. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10812066 ↗
• MalfunctionJul 16, 2020Crack; Crack

  IT WAS REPORTED THAT THE GENESIS II PS HI FLEX INSERT TRIAL S5-6 10 CRACKED. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10286315 ↗