GENESIS II 71430432Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010484925), received between Apr 6, 2021 and Jun 30, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 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 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE ROBOT BUR CHIPPED ONE (1) GII OVAL RESURF PAT TRIAL 32MM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356953 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED THAT, A GII OVAL PATELLA 5 PT. SZ GDE BROKE OFF AND WAS THROWN AWAY. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611472 ↗
• 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 12164317 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT A GII OVAL RESURF PAT TRIAL 32MM WAS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813915 ↗
• MalfunctionApr 6, 2021Break; Break

  IT WAS REPORTED THAT THE PATELLA TRIAL WAS BROKEN DURING A TOTAL KNEE ARTHROPLASTY. INSTRUMENT OUTSIDE THE PATIENT. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617543 ↗