GENESIS II 71420384Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010207357), received between Jun 19, 2019 and May 12, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA, A SECOND STAGE REVISION WAS PERFORMED ON (B)(6) 2021 TO REMOVE THE POLY TIBIA AND COBALT CHROME FEMUR. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815834 ↗
• InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PROSTHESIS WAS REMOVED DUE TO INFECTION BEING CLEARED UP IN A SECOND STAGE REVISION SURGERY. FIRST STAGE SURGERY WAS PURELY TO TREAT INFECTION AND NO COMPONENTS WHERE REMOVED UNTIL SECOND STAGE.

  Patient problems: Unspecified Infection

  MAUDE report 8712936 ↗