GENESIS II 71433456Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556480625), received between Jul 16, 2020 and Jun 12, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 14671977 ↗
• 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 14671927 ↗
• 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 14671786 ↗
• MalfunctionFeb 16, 2022Crack; Crack

  IT WAS REPORTED THAT THE GENESIS II PS HI FLEX INSERT TR S5-6 12 HAD A SLICE IN IT DUE TOO A CUT BEING DONE TOO DEEP. SINCE THIS WAS NOTICED DURING A FIELD INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540360 ↗
• MalfunctionFeb 9, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING INSPECTION, A GII PS HI FLEX ISRT TR S5-6 12 WAS FOUND WITH CRACKS, MAKING THEM UNFIT FOR FURTHER USE IN SURGERY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13499941 ↗
• MalfunctionNov 10, 2020Crack; Crack

  IT WAS REPORTED THAT THE DEVICE HAS A CRACK. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10814857 ↗
• MalfunctionAug 28, 2020Break; Break

  IT WAS REPORTED THAT A GENESIS II PS HIGH FLEXION INSERT TRIAL S5-6 12 HAS A CRACK IN POLY TRIAL. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10469249 ↗
• MalfunctionJul 16, 2020Crack; Crack

  IT WAS REPORTED THAT THE TRIAL IS 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 10284285 ↗