GENESIS II 71420116Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010206022), received between Feb 8, 2018 and Dec 27, 2019 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Injury

  MAUDE report 9527899 ↗
• InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON 10-18-2019 DUE TO THE INFECTION AND LOOSENING. PRIMARY SURGERY WAS PERFORMED ON 1-21-2011 AND GII FEM COMPONENT(71420052), GII TIB BASE(71420180), LEGION INSERT(71453202), PATELLA(71420580). ALL OF THE IMPLANTED DEVICES WERE REVISED. THE REVISED DEVICES WILL NOT BE RETURNED. THE DOCTOR DOES NOT CONSIDER AS THE FAILURE OF DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 9351740 ↗
• InjuryMar 28, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT WHEN THEY OPENED THE BOX OF THE MENTIONED REFERENCE, A LEFT IMPLANT WAS EXPECTED BUT INSIDE A RIGHT IMPLANT WAS FOUND. THE IMPLANT WAS USED AND WE REALIZED ONCE SURGERY WAS COMPLETED. NO DELAY WAS REPORTED AND A REVISION SURGERY WAS PERFORMED DUE TO THIS INCIDENT.

  Patient problems: Injury

  MAUDE report 8460594 ↗
• InjuryNov 26, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS REPORTED DUE TO THIRD PARTY EROSION CAUSED BONE RESORPTION AND LOOSENING OF THE IMPLANT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 8101474 ↗
• InjurySep 27, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVSION SURGERY WAS PERFOMED DUE TO LOOSENING OF THE FEMORAL COMPONENT. DEVICES REVISED TO LEGION COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 7916899 ↗
• InjuryFeb 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO GONARTHROSIS AND INSTABILITY IN KNEE.

  Patient problems: Injury

  MAUDE report 7251884 ↗

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