GENESIS II 71420008Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010205452), received between Jun 26, 2017 and Jan 28, 2026 — classified as 3 injuries.

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

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKR SURGERY PERFORMED APPROXIMATELY 2 YEARS AGO, THE PATIENT EXPERIENCED A CATASTROPHIC FAILURE OF THE MEDIAL COLLATERAL LIGAMENT. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2026, DURING WHICH A HINGED PROSTHESIS WAS REQUIRED. AS A RESULT, THE GNS II C/R FEM SIZE 5 LEFT AND GNS II CMT TIB SIZE 4 LEFT WERE REMOVED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Damage to Ligament(s); Deformity/ Disfigurement; Inadequate Osseointegration; Joint Dislocation

  MAUDE report 24199287 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA, A SECOND STAGE REVISION WAS PERFORMED ON (B)(6) 2021 TO REMOVE THE POLY TIBIA AND COBALT CHROME FEMUR. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815820 ↗
• InjuryJun 26, 2017Unstable; Unstable

  IT WAS REPORTED A REVISION SURGERY REQUIRED AFTER THE PATIENT HAD A TRAUMATIC FALL RESULTING IN AN UNSTABLE KNEE. PATIENT WAS REVISED TO A LEGION CONSTRAINED IMPLANT.

  Patient problems: Fall

  MAUDE report 6668514 ↗

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