GENESIS II 71420966Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010210135), received between Nov 11, 2021 and Jul 2, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K962137); they may or may not involve this specific model.

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.

• InjuryJul 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA REVISION SURGERY, WHEN OPENING THE KNEE, ONE (1) G2 CONST INSRT SZ1-2 18MM COMPLETELY POPPED OUT. SINCE IT WAS THE SECOND POLY THAT THE PATIENT HAD HAD, IT WAS DECIDED TO PULL OUT ALL THE COMPONENTS WITHOUT ANY DELAY AND REPLACE THEM WITH COMPETITOR DEVICES FROM STRYKER (REVISION/HINGE). THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653771 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2020, THE LEGION REV TIBIA BASEPLATE SZ 2 RIGHT ((B)(4)) BECAME LOOSE DUE TO SEPSIS, SO ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED TO REMOVE THE LEGION REV TIBIA BASEPLATE SZ 2 RIGHT ((B)(4)), THE GENESIS II CONSTRAINED ARTICULAR INSERT SIZE 1-2 18MM ((B)(4)), THE LEGION COBALT CHROME CONSTRAINED FEMORAL SIZE 4 RIGHT ((B)(4)) AND THE LEGION PRESSFIT STEM 14MM X 160MM ((B)(4)). CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Sepsis

  MAUDE report 12796690 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962137. One submission often covers many models, so check the product and lot details in each record.

• Z-0118-2021 · Sep 21, 2020 · Terminated
  Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e.