GENESIS II 71421531Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010520340), received between Sep 20, 2017 and Apr 5, 2023 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionApr 5, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA, GENESIS II CR DEEP FLEX INSERT S1-2 9M COULD NOT BE LOCKED WITH THE TIBIAL BASEPLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH GREATER THAN 30 MINS DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681755 ↗
• MalfunctionApr 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA, GENESIS II CR DEEP FLEX INSERT S1-2 9 M COULD NOT BE LOCKED WITH THE TIBIAL BASEPLATE. THE LOCKING MECHANISM HAD NO OBVIOUS DEFORMATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683548 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem

  REVISED A TKA FROM (B)(6) 2006. THE SURGEON DOES NOT FAULT THE DEVICES.

  Patient problems: No Code Available

  MAUDE report 6881512 ↗