GENESIS II 71420754Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010209269), received between Jun 24, 2019 and Nov 1, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED MRSA INFECTION AND DISCOMFORT. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024 IN WHICH THE GII DISHED INS SZ1-2 9MM WAS EXCHANGED TO A GII DISHED INS SZ1-2 13MM; AND THE LEGION NARROW CR OXIN SZ 3N LT, THE GEN II 7.5MM RESUR PAT 29MM AND THE GNS II CMT TIB SIZE 2 {} LEFT WERE RETAINED. THE SURGEON PRESUMES THE SITUATION IS NOT RELATED TO A DEVICE FAILURE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Discomfort

  MAUDE report 20588589 ↗
• MalfunctionOct 10, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT THE INNER BAG OF ONE (1) GII DISHED INS SZ1-2 9MM WAS NOT SEALED PROPERLY. IT WAS OPEN IN BOTH ENDS, THE IMPLANT FALL TO THE FLOOR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17907155 ↗
• MalfunctionMar 22, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY THE GENESIS II DISHED INS SIZE 1-2 9MM AND THE GENESIS II DISHED ARTICULAR INSERT SIZE 3-4 MM WOULD NOT SEAT INTO TIBIA TRAY. NO DELAY OR INJURY REPORTED. BACKUP DEVICES FROM SMITH AND NEPHEW WERE OPENED AND SEATED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548190 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A REGISTER REPORT FROM EPRD (ENDOPROTHESENREGISTER DEUTSCHLAND) THAT THERE WAS ONE REVISION SURGERY PERFORMED TO REPLACE THE INSERT IMPLANT GENESIS II DISHED INS SIZE 1-2 9MM. THERE IS NO ADDITIONAL INFORMATION ABOUT THE HOSPITAL, PATIENT AND SURGERY DATA. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 11479152 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE POSSIBILITY OF INFECTION. AFTER THE REVISION, IT WAS REALIZED THAT THE PATIENT HAS NOT BEEN SUFFERED FROM THE INFECTION. THE INSERT SEEMED TO BE COVERED WITH THE SOME FORMS.

  Patient problems: Unspecified Infection

  MAUDE report 8727664 ↗

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