GENESIS II 71420184Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 03596010206343), received between Jul 6, 2017 and Jun 19, 2025 — classified as 31 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2025Adverse 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) 2025, THE PATIENT EXPERIENCED FEELING OF WRONGNESS, TIBIAL BASEPLATE LOOSENING AND AFTER SURGERY THERE WAS AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH IMPLANTS WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity; Post Operative Wound Infection

  MAUDE report 22292933 ↗
• MalfunctionJan 2, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A TKA SURGERY, IT WAS FOUND THAT THE BOX OF GNS II CMT TIB SIZE 4 {} RIGHT HAD A SLICE GOING THROUGH BOTH LAYERS OF STERILITY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 21057334 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A CORI-ASSISTED TKA ON (B)(6) 2024 PATIENT EXPERIENCED BILATERAL PULMONARY EMBOLISM. THIS ADVERSE WAS ADDRESSED BY GIVING PATIENT MEDICATION THERAPY ON (B)(6) 2024, IN WHICH THE OUTCOME WAS RESOLVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 20131422 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA PERFORMED ON (B)(6) 2021, THE PATIENT PRESENTED WITH LEG PAIN, AND AN UNSTABLE KNEE. THE KNEE WAS ELECTED FOR REVISION BECAUSE THE GNS II CMT TIB SIZE 4 {} RIGHT COMPONENT WAS MAL-ROTATED AND IN 8 DEGREES OF VARUS. THE TIBIAL BASEPLATE AND INSERT WERE REMOVED ON (B)(6) 2024. AND EXCHANGED FOR A LEGION REVISION SIZE 4 BASEPLATE, WITH A 120MM X 14MM LEGION PRESS FIT STEM AND A 13MM LEGION PS POLY INSERT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19081576 ↗
• InjuryOct 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED THE PATIENT EXPERIENCED A LOOSENING OF THE GNS II CMT TIB SIZE 4 {} RIGHT. THIS ADVERSE EVENT WAS RESOLVED BY REVISION SURGERY ON (B)(6) 2023, WHERE THE LGN CR HIGH FLEX XLPE SZ 1-2 9MM AND THE GNS II CMT TIB SIZE 4 {} RIGHT WERE EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IN UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 17986212 ↗
• InjurySep 29, 2022Loss of Osseointegration; Material Deformation; Loss of Osseointegration; Material Deformation

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT EXPERIENCED A PRESUMED LOOSE TIBIAL COMPONENT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 TO ADDRESS THE ISSUE. DURING REVISION SURGERY, IT WAS FOUND THAT THE RAIL OF A GNS II CMT TIB SIZE 4 RIGHT WAS DEFORMED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15502086 ↗
• InjuryMay 12, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON THE (B)(6) 2019, THE PATIENT EXPERIENCED PAIN. AN IMAGING DONE WITH CONTRAST FOUND THAT THE GNS II CMT TIB SIZE 4 {} RIGHT WAS LOOSE. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 14385787 ↗
• InjuryAug 11, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A PRIMARY SURGERY HAD BEEN DONE 7 YEARS AGO, THE IMPLANTS WERE LOOSENING. THE ADVERSE EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY TO EXPLANT A GENESIS II CMT TIBIAL BASEPLATE SIZE 4 RIGHT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10394003 ↗
• InjuryAug 5, 2020Unstable; Unstable

  IT WAS REPORTED THAT IT WAS REVISED A GEN II TIBIAL BASEPLATE AND POLYETHELENE INSERT FOR ASEPTIC LOOSENING. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10370606 ↗
• InjuryMar 12, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT HAD SN COMPONENTS SINCE (B)(6) 2014. REVISION SURGERY PERFORMED ON (B)(6) 2019 DUE TO COMPLETE LOOSENING AND MASSIVE ABRASION METALLOSIS.

  Patient problems: Injury

  MAUDE report 9824464 ↗
• MalfunctionFeb 19, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A GENESIS II CASE, A TIBIA SIZE 4 BASE PLATE WAS ACCIDENTALLY PUT INTO THE JOURNEY II IMPLANT TUB. WHEN OPENING THE IMPLANTS FOR THE SURGERY TO IMPLANT I MISSED THE NAME ON THE BOX THAT IT WAS A GENESIS II TIBIA INSTEAD OF A JOURNEY II TIBIA. THE BOXES ARE IDENTICAL LOOKING. IT WAS A JOURNEY II CASE. THE JOURNEY II POLY WAS PLACED IN THE GENESIS II TIBIA WITH NO INCIDENT AT ALL. IT SNAPPED IN FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729360 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9586222 ↗
• InjuryDec 30, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING SURGERY (BILATERAL KNEE REPLACEMENT), A COMPONENT FOR THE RIGHT SIDE WAS IMPLANTED IN THE LEFT KNEE. AFTER EXPLANTATION OF THE DEVICE, THERE WAS SOME DAMAGE (BONE LOSS), TO SOLVE THIS PROBLEM THE BONE WAS COVERED WITH ADDITIONAL CEMENT. BECAUSE OF THE MIXUP PREVIOUSLY DESCRIVED, THE DEVICES FOR THE RIGHT KNEE WERE NO LONGER AVAILABLE, IT WAS RESOLVED TO USE A DIFFERENT SIZE SYSTEM IN ORDER TO COMPLETE THE PROCEDURE. DELAY GREATER THAN 30 MIN. NO BACK UPS WERE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9532455 ↗
• InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN. THE SURGEON STATED THAT IT COULD BE RELATED TO EITHER PAIN OR AN ALLERGIC REACTION. ADDITIONALLY, REPORTS OF THE IMPLANTS ARE NOT NECESSARY AND THEY ARE NOT AVAILABLE FOR EVALUATION. DEVICES WILL BE EXCHANGED FOR CEMENT MOLDS.

  Patient problems: Pain

  MAUDE report 9510797 ↗
• InjuryDec 3, 2019Adverse 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 UNKNOWN REASONS. S&N WAS RETRIEVED. FURTHER INFORMATION REQUESTED.

  Patient problems: No Information

  MAUDE report 9401200 ↗
• InjuryNov 13, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING, THE TIBIA WAS REPLACED.

  Patient problems: Injury

  MAUDE report 9315154 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 9255795 ↗
• InjuryOct 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT TWO DAYS AFTER PRIMARY KNEE REPLACEMENT DISCHARGE, PATIENT RETURNED TO THE HOSPITAL WITH SURGICAL INFECTION WITH FOLLOW-UP OF 8 DAYS OF HOSPITALIZATION.

  Patient problems: Unspecified Infection

  MAUDE report 9216052 ↗
• InjuryAug 24, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT HAD PRIMARY SURGERY IN 2018 AND ITS COMPONENTS ARE LOOSE BUT NO REVISION SURGERY HAS BEEN PERFORMED.

  Patient problems: Injury

  MAUDE report 8928681 ↗
• InjuryJun 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION OF THE INSERT. NO MORE INFORMATION REPORTED YET.

  Patient problems: Joint Dislocation

  MAUDE report 8742860 ↗
• InjuryApr 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A ASEPTIC LOOSENING OF TIBIA.

  Patient problems: Injury

  MAUDE report 8547204 ↗
• InjuryApr 5, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT RIGHT KNEE REVISION SURGERY WAS PERFORMED DUE TO LOOSE TIBIA.

  Patient problems: Injury

  MAUDE report 8488982 ↗
• InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8374633 ↗
• InjuryFeb 26, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO INSTABILITY. NO ADDITIONAL INJURIES REPORTED.

  Patient problems: Injury

  MAUDE report 8369960 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF SMITH AND NEPHEW DEVICES WAS PERFORMED DUE TO A CHRONIC UNTREATABLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8283295 ↗

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