GENESIS II 71420160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010206237), received between Jun 26, 2018 and Aug 28, 2018 — classified as 2 injuries.

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

6 other recalls cover devices cleared under the same FDA submission (K951987); 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.

• InjuryAug 28, 2018Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING TKA PROCEDURE, THE SURGEON DECIDED TO IMPLANT JOURNEY II, AND PROCEDURE WAS COMPLETED. WHEN CHART-STICK LABEL WAS CHECKED 2DAYS LATER, IT WAS FOUND THAT INCORRECT BASE PLATE WAS IMPLANTED TO THE PATIENT. IT MEAN THAT JOURNEY II BCS FEMORAL COMPONENT, JOURNEY II BCS INSERT AND GENESIS II BASE PLATE WERE IMPLANTED TO THE PATIENT. THE INCORRECT PRODUCT (COMBINATION) WAS IMPLANTED. (JOURNEY II INSERT WAS IMPLANTED TO THE GENESIS II BASE PLATE).

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7824750 ↗
• InjuryJun 26, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE LEGION INSERT BEING DISASSOCIATED FROM THE BASEPLATE.

  Patient problems: No Information

  MAUDE report 7638373 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951987. One submission often covers many models, so check the product and lot details in each record.

• Z-1418-2022 · Jun 27, 2022 · Terminated
  (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
• Z-2774-2020 · Jul 16, 2020 · Open, Classified
  Tibial knee prosthesis
• Z-2883-2018 · Aug 1, 2017 · Terminated
  GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
• Z-0573-2016 · Nov 9, 2015 · Terminated
  Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 kn
• Z-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic