GENESIS II 71420108Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010205988), received between Apr 24, 2018 and Jan 4, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) GII NONPOROUS PS FEM SZ 7 LT WAS TAKEN OUT OF THE STERILE CONTAINER AND IT WAS NOTED TO HAVE THREE SMALL SCRATCHES ON THE LATERAL SIDE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099250 ↗
• MalfunctionJul 30, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING SURGERY IT WAS NOTICED THAT THE COMPONENT WAS DAMAGED. THERE WAS NO BACKUP DEVICE AVAILABLE SO PROCEDURE HAD A DELAY OF AN HOUR WHILE BACKUP FROM SMITH AND NEPHEW ARRIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8844088 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASONS, ONCE THE DEVICE WAS REMOVED THE DOCTOR NOTICES IT WAS WORN.

  Patient problems: Injury

  MAUDE report 8042085 ↗
• InjuryApr 24, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 7454993 ↗

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