GENESIS II 71420962Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010210111), received between Dec 1, 2017 and Jun 6, 2023 — classified as 2 injuries, 1 malfunction.

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

• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6)2023, THE PATIENT EXPERIENCED ANTERIOR TIBIAL FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6)2023, IN WHICH TIBIAL COMPONENTS WERE REPLACED WHILE FIXING THE FRACTURE.. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 17075997 ↗
• MalfunctionDec 29, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A GENESIS II CONSTRAINED ARTICULAR INSERT SIZE 1-2 13MM 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 OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114877 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE INSERT HAD DISENGAGED FROM THE METAL TIBIAL BASEPLATE .

  Patient problems: Injury

  MAUDE report 7076660 ↗

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.