GENESIS II 71430510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010212153), received between Aug 20, 2020 and Mar 30, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2021Crack; Crack

  IT WAS REPORTED THAT A TKA THE GENESIS II C/R ART TR SIZE 7-8 9MM MIGHT BE CRACKED. AS THIS WAS NOTICED AFTER THE PROCEDURE, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593387 ↗
• MalfunctionDec 16, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE G2 C/R ART TR SZ7-8 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 11017009 ↗
• MalfunctionAug 20, 2020Break; Break

  IT WAS REPORTED THAT, DURING OFFICE INSPECTION PROCESS, THE G2 C/R ART TR SZ7-8 9MM INSERT WAS FOUND CHIPPED AND/OR DAMAGED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10431176 ↗