GENESIS II 71430578Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010212238), received between May 25, 2021 and Sep 17, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) GNS II RESURF PAT TR 35MM BROKE BY ONE OF THE PEGS COMING OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED, NOR IF ANY PIECE FELL INSIDE THE PATIENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241716 ↗
• MalfunctionJun 2, 2022Crack; Crack

  IT WAS REPORTED THAT THE GNS II RESURF PAT TR 35MM CRACKED AND NEEDS TO BE REPLACED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580037 ↗
• MalfunctionMay 25, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A GNS II RESURF PAT TR 35MM BROKE. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501149 ↗
• MalfunctionNov 9, 2021Crack; Crack

  IT WAS REPORTED, THAT DURING THE SET UP FOR A TKA, A GNS II RESURF PAT TR 35MM HAD A CRACK IN IT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778198 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, ONE (1) GENESIS II RESURFACING PATELLA TRIAL 35MM BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM AND NO PIECES FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201219 ↗
• MalfunctionJun 29, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY SURGERY, A GENESIS II RESURFACING PATELLA TRIAL 35MM PRESENTED A CRACK DUE TO WEAR AND TEAR. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12087270 ↗
• MalfunctionMay 25, 2021Break; Break

  IT WAS REPORTED THAT, A GNS II RESURF PAT TR 35MM BROKE. AS THIS WAS NOTICE IN A CENTRAL STERILE, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11880526 ↗