GENESIS II 71420960Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010210104), received between May 23, 2017 and May 9, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Positioning Failure; Unstable; Positioning Failure; Unstable

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN INSTALLING THE G2 CONST INSRT SZ1-2 11MM, IT WAS FOUND THAT THE GAP BETWEEN THE INSERT AND THE TIBIAL BASEPLATE WAS LARGE, THE INSERT WAS UNSTABLE AND THERE WAS A RISK OF DISLOCATION. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896985 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED SWELLING, FEVER AND INFECTION. THIS ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022. THE G2 CONST INSRT SZ1-2 11MM WAS EXPLANTED. THE DOCTOR SAID THE DEVICES WERE NOT DEFECTIVE. PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 13451209 ↗
• MalfunctionDec 29, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A GENESIS II CONSTRAINED ARTICULAR INSERT SIZE 1-2 11MM WAS NOT ENGAGING. THE LOCKING MECHANISM WAS OBSERVED TO BE DAMAGED. SURGERY WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114871 ↗
• InjuryMay 23, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY WITH EXCHANGE OF TIBIAL INSERT DUE TO IT BEING DISENGAGED. PATIENT WAS PRESENTED TO SURGEON IN (B)(6). WITH REDUCED RANGE OF MOTION AND NO OTHER COMPLICATIONS. X-RAY SHOWED THE LINER HAD DISENGAGED. REVIEW OF X-RAYS ONE DAY POST-OP REVEALED THE LINER ALREADY DISENGAGED THEN BUT HAD NOT BEEN IDENTIFIED. ALL OTHER COMPONENTS ARE SATISFACTORY.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 6584354 ↗

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.