GENESIS II 71421538Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010512468), received between Jan 4, 2018 and Sep 15, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• InjurySep 15, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS NOTED WITH STIFFNESS POST LEFT TKR FOR WHICH MANIPULATION UNDER ANESTHESIA WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 9060665 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE A HORSEFLY BIT THE PATIENT ON A REPLACED KNEE. DR DECIDED TO REPLACE THE POLY DEVICE AND CLEAN THE KNEE (PULSE LAVAGE & ANTIBIOTICS).

  Patient problems: Injury; Swelling

  MAUDE report 8028284 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PATIENT PRESENTED STIFFNESS AND PAIN. POLYETHYLENE INSERT WAS REPLACED FOR A THINNER COMPONENT.

  Patient problems: Injury

  MAUDE report 7166559 ↗