GENESIS II 71430490Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010212115), received between Jul 20, 2020 and May 1, 2025 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A TKA SURGERY PIECES FROM ONE (1) G2 C/R ART TR SZ3-4 9MM WAS CUT UP. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAY OR INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943339 ↗
• MalfunctionDec 26, 2023Flaked; Flaked

  IT WAS REPORTED THAT, DURING TKA SURGERY, A G2 C/R ART TR SZ3-4 9MM HAS FLAKING AND CHIPS. 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 18395175 ↗
• MalfunctionFeb 7, 2021Break; Break

  IT WAS REPORTED THAT DURING CONSIGNMENT INSPECTION THE G2 C/R ART TR SZ3-4 9MM WAS FOUND TO BE BROKEN. NO CASE INVOLVED. NO INJURY TO PATIENT. 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 11290841 ↗
• MalfunctionJan 28, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP WAS FOUND THE ITEM TO BE BROKEN TRIAL. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11248088 ↗
• MalfunctionDec 16, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE G2 C/R ART TR SZ3-4 9MM IS PRESENTING WEAR AND TEAR. IT HAS CHIPS AND CRACKS. NO CASE RELATED. 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 11016816 ↗
• InjuryJul 20, 2020Break; Break

  IT WAS REPORTED THAT DURING A TKR THE SIZE 3-4 (9MM) GENESIS II CRUCIATE RETAINING INSERT BROKE OFF WHEN THE SURGEON WAS ATTEMPTING TO TRIAL THE KNEE. NO PIECES WERE LEFT IN THE PATIENT AND NO TIME ADDED TO THE PROCEDURE. ALL THE PIECES WERE RECOVERED AND NO SURGICAL INTERVENTION NEEDED. IT WAS ANOTHER INSERT IN THE ROOM AND USED IT IN PLACE OF THE DAMAGED INSERT. NO TIME WAS ADDED TO THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 10296218 ↗