GENESIS II 71420544Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010208149), received between Feb 9, 2022 and Mar 24, 2026 — classified as 4 injuries.

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.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2025, PATIENT EXPERIENCED INFECTION OF UNKNOWN ORIGIN. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2026, DURING WHICH, THE GNS II CON INS SZ5-6 18MM & GII NONPOROUS PS FEM SZ 5 RT WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: Medical device site infection

  MAUDE report 24675895 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY 5 YEARS AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN INFECTION AND UNDERWENT A REVISION SURGERY ON (B)(6) 2022 TO REMOVE AND REPLACE THE GNS II CON INS SZ5-6 18MM WITH A 21MM INSERT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16121717 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY ON (B)(6) 2022. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 14192066 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED IN 2009, THE PATIENT EXPERIENCED AN E. COLI INFECTION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE GENESIS II CONSTRAINED ARTICULAR INSERT SIZE 5-6 18MM WAS EXPLANTED AND REPLACED. IRRIGATION AND DEBRIDEMENT WERE PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 13499345 ↗

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