GENESIS II 71420766Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010209320), received between Jan 8, 2018 and Jul 2, 2024 — classified as 6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA SURGERY, AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO INSERT THE GII DISHED INS SZ 3-4 9MM DEVICE, THE SURGEON THINKS THE DEVICE IS DEFECTIVE. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT 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 19662014 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A WASHOUT OF A TKR WAS PERFORMED DUE TO PAIN AND INFLAMMATION, INFECTION WAS NOT CONFIRMED BUT THE PATELLAR BUTTON WAS LOOSENED AND THE POLYETHYLENE WAS ALSO EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Failure of Implant; Inflammation; Pain

  MAUDE report 12145015 ↗
• 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 11548205 ↗
• 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 (B)(4)) THAT THERE WERE THIRTEEN REVISION SURGERIES PERFORMED TO REPLACE THE INSERT IMPLANT GENESIS II DISHED INS SIZE 3-4 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 11479171 ↗
• InjuryNov 24, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE PROCEDURE (TOTAL ARTHROPLASTY OF THE RIGHT KNEE), WHEN THE DEVICE WAS PLACED (3-4, 9MM), IT WAS NOT POSSIBLE SINCE THE INSERT DIDN´T FULLY ENTER IN THE TIBIAL PLATE. AFTER SEVERAL ATTEMPTS TO PLACE IT, IT WAS NECESSARY TO REMOVE IT IN ORDER TO USE A DEVICE BIGGER (3-4, 11MM). THERE WAS NO DAMAGE TO THE PATIENT SINCE THE FAILURE DEVICE WAS REMOVED COMPLETELY AND A SMITH + NEPHEW BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10892246 ↗
• InjuryOct 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. POLY WAS EXCHANGED. DEVICE WILL NOT BE RETURNED. XRAYS NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9199341 ↗
• InjuryJul 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRIMARY SURGERY WAS ON (B)(6) 2018. PAIN IS NOT DECREASING AND THE RANGE OF MOVEMENT WAS REDUCED. SHE IS NOT ABLE TO EXTEND OR BEND THE KNEE. PATIENT HAS TAKEN CONSTANT PHYSICAL THERAPY BUT WITH NO IMPROVEMENT. THE DOCTOR SUGGEST ANOTHER SURGERY TO REMOVE EXCESSIVE SCAR TISSUE THAT WAS BUILT UP AROUND THE KNEE JOINT, BUT THE OUTCOME IS THE SAME, NO RANGE OF MOTION AND PAIN.

  Patient problems: Injury

  MAUDE report 7726256 ↗
• InjuryJan 8, 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 PAIN AND PATELLOFEMORAL MISALIGNMENT, WITH A SQUINTING PATELLA.

  Patient problems: Pain

  MAUDE report 7171666 ↗

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