GENESIS II 71422034Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010496256), received between Oct 22, 2020 and Oct 15, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE , THE PATIENT EXPERIENCED RIGHT KNEE INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON AN UNKNOWN DATE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12639614 ↗
• MalfunctionOct 22, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING SET UP/ INSPECTION THE GII C/R HA POROUS FEM SZ 7RT WAS OPENED AND SCRATCHES WERE NOTED ON DISTAL MEDIAL SECTION. ANOTHER IMPLANT WAS OPENED. SURGERY WAS NOT DELAYED. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10720624 ↗