GENESIS II 71430429Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010484918), received between Sep 8, 2020 and Feb 9, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionFeb 9, 2022Break; Break

  IT WAS REPORTED THAT A GENESIS II OVAL RESURFACING PATELLAR TRIAL 29MM BROKE. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNCERTAIN. THEREFORE, PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 13502788 ↗
• MalfunctionJul 13, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT, THREE (3) PATELLA TRIALS GII OVAL RESURF PAT TRIAL 35MM, GII OVAL RESURF PAT TRIAL 29MM AND GII OVAL RESURF PAT TRIAL 32MM, HAVE DEEP SCRATCHES AND SMALL CHUNKS MISSING. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164313 ↗
• MalfunctionSep 8, 2020Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT THE PATELLA TRIAL WAS FOUND BROKEN / DULL. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10505181 ↗