GENESIS II 71420012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010205483), received between Aug 22, 2019 and Jul 26, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED AROUND 9 YEARS AGO, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO A SUSTAINED PERIPROSTHETIC FRACTURE OF THE FEMUR AFTER THE PATIENT HAD A FALL AND FRACTURED THE FEMORAL CONDYLES. DUE TO THE FRACTURE AND THE COLLATERAL LIGAMENTS BEING COMPROMISED, THE SURGEON ELECTED TO REMOVE ALL COMPONENTS AND REPLACE THEM WITH A HINGE TYPE REVISION SYSTEM. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Fall; Limb Fracture

  MAUDE report 15105557 ↗
• MalfunctionAug 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO POLY DISENGAGE. ALSO IT WAS NOTED THAT THERE WAS MINIMAL SCRATCHING ON THE FEMUR, AND THE LOCKING MECHANISM ON THE TIBIA WAS DAMAGED, THEREFORE, SURGEON DECIDED TO MOVE AHEAD WITH FULL REVISION SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920515 ↗

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