GENESIS II 71420168Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010206275), received between May 22, 2017 and Feb 19, 2025 — classified as 22 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2025Loosening 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 (B)(6) 2020, THE PATIENT EXPERIENCED MULTIPLE FALLS AND THE GNS II CMT TIB SIZE 5 {} LEFT BECAME LOOSE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LOOSE TIBIAL COMPONENT AND INSERT WERE REMOVED AND REPLACED WITH A LEGION REVISION BASEPLATE WITH OFFSET AND CEMENTED STEM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Aseptic loosening; Fall; Inadequate Osseointegration

  MAUDE report 21410559 ↗
• InjuryMar 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY DONE ON (B)(6) WHERE A GNS II CMT TIB SIZE 5 LEFT WAS IMPLANTED, A REVISION SURGERY WAS EXECUTED ON (B)(6) 2023 DUE TO THE LOOSENING OF THE TIBIAL COMPONENT. THE SURGEON HAS SUGGESTED THAT THE LOOSENING OCCURRED AT THE CEMENT-IMPLANT INTERFACE, AND NOT THE CEMENT-BONE INTERFACE. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16570473 ↗
• InjuryMar 16, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED WITH A GENESIS II SYSTEM ON (B)(6) 2016, THE PATIENT EXPERIENCED A TIBIA LOOSENING. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16558938 ↗
• InjuryJul 2, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA ON 2016, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO LOOSENING. A GNS II CMT TIB SIZE 5 LEFT AND A LGN PS HIGH FLEX XLPE SZ 5-6 11MM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 12112015 ↗
• MalfunctionMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT PRESENTED STIFFNESS. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE GNS II CMT TIB SIZE 5 LEFT ((B)(4)), GII OXIN P/S FEM LEFT SZ 6 ((B)(4)) AND LGN PS HIGH FLEX XLPE SZ 5-6 9MM ((B)(4)). THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11797595 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CHRONIC INFECTION IT WAS DECIDED TO EXPLANTED THE IMPLANTS, GII OXINIUM FEM SIZE 4 LEFT, GNS II CMT TIB SIZE 5 LEFT AND LGN XLPE DISHED ISRT SZ 5-6 9MM. SITE WAS WASHED OUT. ONCE WOUND WAS OPENED SAMPLES WERE TAKEN AND SENT TO HISTOLOGY. A COCR GENII FEMUR AND ALL POLY TIBIA WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11449981 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT PRESENTED TO THE HOSPITAL WITH A PSYCHIATRIC ILLNESS. DURING THE EVALUATION, THE LEFT KNEE AND LEFT LEG WERE FOUND TO BE SWOLLEN AND PAINFUL PROXIMALLY. THE LEFT KNEE WAS ASPIRATED AND FOUND TO HAVE VISIBLE PUS, SO THE PATIENT WAS BOOKED FOR REVISION OF THE FIRST STAGE OF THE LEFT KNEE ARTHROPLASTY AND REMOVAL OF ALL HARDWARE. A REVISION SURGERY WAS PERFORMED TO REMOVE ALL PROSTHESES AND INSERT AN ANTIBIOTIC SPACER. AFTER REMOVAL OF THE PROSTHESIS, PUS WAS VISUALIZED IN THE TIBIAL AND FEMORAL CANALS, LAVAGE WAS PERFORMED, AND A SPACER WAS INSERTED.

  Patient problems: Bacterial Infection; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 11167456 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF GEN II WAS PERFORMED DUE TO AN UNSPECIFIED REASON. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11018651 ↗
• InjuryFeb 12, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT HAD S&N COMPONENTS SINCE (B)(6) 2012. THE KNEE WAS REVISED FOR LOOSENING DUE TO OSTEOLYSIS AND POSSIBLE INFECTION. ALL COMPONENTS WERE REMOVED TODAY AND REPLACED WITH A CEMENT SPACER AND A LEGION DISHED 5-6 13MM POLY.

  Patient problems: Injury

  MAUDE report 9699488 ↗
• InjurySep 24, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE GII TIBIA WAS EX-PLANTED DURING A REVISION SURGERY ON AUGUST 5TH. ITEM WAS LEFT AT THE HOSPITAL AND THE SURGEON IS REQUESTING AN INVESTIGATION AS TO THE CAUSE OF WHY THE TIBIA WAS LOOSENED IN THE PATIENT.

  Patient problems: Joint Dislocation

  MAUDE report 9109066 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND UNDERWENT A WASHOUT DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8931584 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ARTHROSCOPY WAS PERFORMED DUE TO KNEE EFFUSION AND PAIN AN ADDITIONALLY AN ASPIRATION AND A CORTISONE INJECTION WERE GIVEN A MONTH AFTER.

  Patient problems: Injury; Pain

  MAUDE report 8349336 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER TWO UNSUCCESSFUL ASPIRATION ATTEMPTS DUE TO PAIN AND EFFUSION, A KNEE ARTHROSCOPY WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8348519 ↗
• InjuryDec 2, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED SINCE THE IMPLANTS MOVED POSITION FROM PRIMARY SURGERY. THE GENESIS II SIZE 5 TIBIA AND 5/6 9MM INSERT WERE REMOVED AND REPLACED.

  Patient problems: Injury

  MAUDE report 8123249 ↗
• 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; Unspecified Infection

  MAUDE report 8034906 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REGIONAL THREE PHASE BONE SCAN OF THE KNEES WAS PERFORMED.

  Patient problems: No Code Available

  MAUDE report 7949871 ↗
• InjuryOct 3, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FAILURE OF THE DEVICE. SWEELING WAS REPORTED.

  Patient problems: Swelling

  MAUDE report 7931023 ↗
• InjuryOct 1, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING OF THE LEFT TOTAL KNEE ARTHROPLASTY.

  Patient problems: Injury

  MAUDE report 7922098 ↗
• InjuryMay 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 FAULTY CEMENT AND MECHANISM.

  Patient problems: Injury

  MAUDE report 7494733 ↗
• InjuryMar 13, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT FELL AND THEN COMPLAINED OF PAIN IN THEIR KNEE. UPON SEEING THE PATIENT, DR. DETERMINED THAT THE PATIENT HAD DAMAGED THEIR PCL. THE PRIMARY KNEE IMPLANTS IN THE PATIENTS KNEE SEEMED TO BE LOOSE. A REVISION WAS DONE TO CORRECT THE PATIENTS KNEE PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7333308 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH PAIN AND UNDERWENT ASPIRATION OF THE KNEE AND NERVE BLOCK ABLATION IN THE KNEE.

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 7109898 ↗
• InjurySep 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 6881283 ↗
• InjuryMay 22, 2017Device Slipped; Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY WITH EXCHANGE OF LEFT TIBIAL BASE PLATE AND ARTICULARY INSERT DUE TO LOOSENING OF THE BASEPLATE. PER REPORT THE TIBIAL BASE TRAY WAS FOUND TO BE LOOSE WITH NO CEMENT ON THE UNDERSIDE OF THE TIBIAL BASE TRAY.

  Patient problems: Failure of Implant

  MAUDE report 6581034 ↗

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