GENESIS II 71420482Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010207852), received between Feb 16, 2021 and Dec 20, 2021 — classified as 1 injury, 2 malfunctions.

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

• InjuryDec 20, 2021Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT, DURING A TKA SURGERY A GII C/R ART INS SZ 1-2 11MM WAS NOT ASSEMBLED. SURGERY WAS FINISHED WITH A S&N BACK UP DEVICE, WITH A DELAY GREATER THAN 30 MINUTES. PATIENT WAS NOT INJURED AS CONSEQUENCE F THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047685 ↗
• MalfunctionFeb 16, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA, THE GII C/R ART INS SZ 1-2 11MM WAS NOT LOCKING PROPERLY. THE INSERT WAS REMOVED AND A NEW INSERT WAS OPENED BUT THAT INSERT ALSO NOT LOCKING PROPERLY. PROCEDURE FINISHED WITH BACKUP DEVICE. DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332985 ↗
• MalfunctionFeb 16, 2021Break; Break

  IT WAS REPORTED THAT AFTER A THR, WHEN CLEANING UP THE REP NOTICED THE MI TRIAL FEM HEAD 36 +0 WAS BROKEN. PROCEDURE FINISHED WITH SAME DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332979 ↗

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-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
• Z-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic