GENESIS II 71430435Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010484932), received between Jul 6, 2020 and Aug 27, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BUTTON OF A GII OVAL RESURF PAT TRIAL 35MM BROKE. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075000 ↗
• InjuryOct 28, 2021Break; Break

  IT WAS REPORTED, THAT DURING A TKA A GENESIS II OVAL RESURF PAT TRIAL 35MM BROKE INSIDE THE PATIENT. ALL PIECES WERE RETRIEVED. SURGERY WAS COMPLETED, WITHOUT DELAY, BY USING A BACK-UP DEVICE. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715831 ↗
• 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 12164304 ↗
• InjuryJul 6, 2020Crack; Crack

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE PATELLA TRIAL MADE CONTACT WITH A NAVIO BURR. DEVICE GOT CRACKED/CHIPPED. THE DEVICE WAS BEING USED INSIDE THE PATIENT BUT NO PIECES FELL INSIDE. DEVICE DID NOT BREAK. NO DELAY TO PROCEDURE. SURGERY WAS FINISHED USING THE SAME DEVICE. NO INJURIES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10237518 ↗