GENESIS II 71420552Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010208187), received between Apr 4, 2021 and Apr 20, 2023 — classified as 3 injuries, 1 malfunction.

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

• MalfunctionApr 20, 2023Positioning Failure; Dent in Material; Positioning Failure; Dent in Material

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GNS II CON INS SZ7-8 11MM COULD NOT BE "CLICKED" INTO PLACE. SEVERAL ATTEMPTS WERE NECESSARY, BUT WITHOUT SUCCESS. THE GNS II CON INS SZ7-8 11MM HAD A DENT ON THE BACK. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781891 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR, A PATIENT PRESENTED WITH FIBROSIS CAUSING PAIN AND REDUCED RANGE OF MOTION (KNEE). THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A GNS II CON INS SZ7-8 11MM WAS REMOVED AND PATIENT´S KNEE WAS DEBRIDED OF FIBROSIS TISSUES. A NEW TIBIAL INSERT WAS PLACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fibrosis; Loss of Range of Motion; Pain

  MAUDE report 15901709 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT PRESENTED AN INFECTED KNEE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, WASHOUT WAS PERFORMED AND A GNS II CON INS SZ7-8 11MM WAS EXCHANGED WITH 7/8 X 13MM CONSTRAINED INSERT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 15777511 ↗
• InjuryApr 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2021 DUE TO A LUXATED INLAY. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020. THE GNS II CON INS SZ7-8 11MM WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611971 ↗

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