GENESIS II 71420568Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010208262), received between Nov 30, 2017 and Mar 18, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT COMPLAINED OF DISCOMFORT, AND IT WAS NOTICED THROUGH X-RAY THAT ONE (1) GNS II BICONVEX PAT 26MM WAS DISSOCIATED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026. THE CURRENT PATIENT'S STATUS IS UNKNOWN. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 24626620 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2018 AND AN INSERT AND PATELLA COMPONENT EXCHANGE PERFORMED ON (B)(6) 2019, DUE TO UNKNOWN REASONS, AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2020 TO EXCHANGE THE PATELLAR COMPONENT GNS II BICONVEX PAT 26MM. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21056203 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AVASCULAR NECROSIS OF THE PATELLA WHICH CAUSED THE COMPONENT TO BECOME LOOSE AND DISLODGED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A GNS II BICONVEX PAT 26MM WAS EXCHANGED. PATIENT HAS BEEN DISCHARGED AND IS RECOVERING.

  Patient problems: Inadequate Osseointegration; Necrosis

  MAUDE report 15538406 ↗
• InjuryFeb 12, 2021Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE DUE TO THE RELEASE OF THE BICONVEX PATELLA BUTTON. THE PATIENT SUFFERED PAIN AND LIMITED FUNCTION. BROKEN POST BEHIND THE PATELLA BUTTON WAS FOUND WITH VISUAL INSPECTION. PRIMARY SURGERY WAS PERFORMED 2.5 YEARS AGO.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11321695 ↗
• InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE LOOSENING OF FEMORAL COMPONENT AND PAIN. PRIMARY OPERATION WAS PERFORMED ON (B)(6) 2019. THERE WAS NO PROBLEM AT THAT TIME, AND THERE WAS NO FINDINGS OF INFLAMMATION LIKE ARTHROFIBROSIS, NOR INFECTION. ON (B)(6) 2020 REVISION SURGERY WAS PERFORMED AND FEMORAL COMPONENT, TIBIAL COMPONENT, INSERT AND PATELLA WERE REMOVED. THE FEMORAL COMPONENT WAS EASY TO REMOVE, BUT THE OTHER COMPONENTS WERE FIXED WELL. THERE WAS A LITTLE RESIDUE OF CEMENT ONTO NON-ARTICULAR SURFACE OF FEMORAL COMPONENT. PATIENT OUTCOME IS GOOD. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 10230728 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN DUE TO AN OVERSTUFFED JOINT AND A LOT OF SCAR TISSUE. A REVISION SURGERY WAS PERFORMED ,REVISED POLY AND THE PATELLA TAKING OUT A BICONVEX AND IMPLANTING A 38MM OVAL PATELLA. THERE WAS NO IMPLANT FAILURE.

  Patient problems: Injury

  MAUDE report 9588738 ↗
• InjuryDec 30, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A PATELLA THAT WAS "FLOATING" INSIDE THE KNEE (CONFIRMED BY A PRE-OP X-RAY). IT WAS REPLACED WITH A 29MM RESURFACING PATELLA. (THE FIRST PATELLA DEVICE WAS IMPLANTED ABOUT 10 YEARS AGO (UNKNOWN DATE)). NO OPERATIVE REPORTS ARE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9533512 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION AND A FEELING OF WRONGNESS CAUSED BY PATIENT'S FALL. PATELLA WAS EXPLANTED.

  Patient problems: Injury

  MAUDE report 9383469 ↗
• InjuryMay 14, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT LOOSENING. REVISED TO INLAY RESURFACING PATELLA.

  Patient problems: Injury

  MAUDE report 8610530 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE DISCOVERY OF A CYST BEHIND THE ORIGINAL POLY PATELLA.

  Patient problems: Injury

  MAUDE report 8172426 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FAILURE OF PATELLA COMPONENT. THE PATELLA COMPONENT WAS REPLACED TO NEW ONE.

  Patient problems: Failure of Implant; Injury

  MAUDE report 8161721 ↗
• InjuryNov 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN INJECTION IN PES ARSENINE BURSA TO RELIEF PERSISTENT PAIN. ALSO CLICKING AND POPPING FELT BY DOCTOR THAT MAY BE RELATED TO CAPSULAR FIBROSIS.

  Patient problems: Pain

  MAUDE report 8036210 ↗
• InjuryNov 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 1ST STAGE REVISION OF A GENESIS II TKR FROM 2004 WAS PERFORMED. IT WAS REVISED DUE TO INFECTION. EARLY THIS YEAR, THE KNEE WAS WASHED OUT, AND THE POLYETHYLENE WAS REVISED IN AN ATTEMPT TO CLEAR THE INFECTION. ORIGINAL OP NOTES ARE NOT AVAILABLE, SO LOT NUMBERS ETC ARE UNAVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 8034891 ↗
• InjuryOct 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY PERFORMED DUE TO PAIN, LOOSENING OF TIBIAL COMPONENT, MALALIGNMENT AND PATELLAR CLUNK SYNDROME.

  Patient problems: Injury

  MAUDE report 7979478 ↗
• InjuryOct 3, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A REVISION OF BIOCONVEX PATELLA IMPLANT. PRIMARY SURGERY 2017. PROGRESSIVE LUCENT LINE ON IMAGING.

  Patient problems: No Code Available

  MAUDE report 7931877 ↗
• InjurySep 3, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PATELLA COMPONENT LOOSENING.

  Patient problems: Injury

  MAUDE report 7840940 ↗
• InjuryJun 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT HAD PAIN AND CRACKING IN KNEE. X-RAY AND SCINTIGRAPHY HAVE SHOWN A LOOSENING OF THE PATELLA IMPLANT.

  Patient problems: Injury

  MAUDE report 7648765 ↗
• InjuryApr 6, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF PATELLAR COMPONENT.

  Patient problems: Failure of Implant

  MAUDE report 7403194 ↗
• InjuryFeb 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING PATELLA.

  Patient problems: Injury; Pain

  MAUDE report 7284289 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH FLEXION CONTRACTURE AND UNDERWENT A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 7069959 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO FLEXION CONTRACTURE. IT WAS ALSO REPORTED THE PATIENT HAD FALLEN DOWN STAIRS AND HAD SWELLING AND PAIN.

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

  MAUDE report 7069953 ↗

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