GENESIS II 71420182Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 03596010206336), received between Apr 27, 2017 and Feb 6, 2026 — classified as 30 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 6, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, AFTER PLAINTIFF UNDERWENT A LEFT TKA SURGERY ON (B)(6) 2022, THE PATIENT HAS BEEN EXPERIENCING PAIN, STIFFNESS AND FUNCTIONAL IMPAIRMENT OF THE LEFT KNEE AS CONSEQUENCE OF IMPLANTING RIGHT-SIDED PROSTHETIC COMPONENTS, INCLUDING A GENESIS II RIGHT NONPOROUS TIBIAL BASEPLATE. THIS ADVERSE EVENT WILL REQUIRE A REVISION SURGERY IN WHICH THE IMPLANTED COMPONENTS WILL BE REMOVED AND REPLACED WITH ANATOMICALLY CORRECT IMPLANTS. CURRENT HEALTH STATUS OF THE PLAINTIFF IS UNKNOWN.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 24277275 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT SURGERY IN 2014 DUE TO DEGENERATIVE ARTHRITIS. DURING THE SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. ON (B)(6) 2014, THE PATIENT SUSTAINED TIBIAL CANAL PERFORATION. IT IS UNKNOWN HOW THIS EVENT WAS TREATED. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Perforation

  MAUDE report 20528234 ↗
• MalfunctionAug 13, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A TKA SURGERY, TWO (2) GII C/R ART INS SZ 3-4 9MM FAILED TO SIT PROPERLY IN THE TIBIA, RESULTING IN DAMAGE TO THE GNS II CMT TIB SIZE 3 {} RIGHT. THE TIBIAL BASEPLATE WAS REMOVED AND REPLACED WITH A NEW TIBIA DURING SURGERY. A SIGNIFICANT DELAY WAS REPORTED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974063 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN AFTER STANDING 20 MINUTES. AN MRI SHOWED THAT THE LEGION XLPE PS INSERT SIZE 3-4 9MM WAS NOT FULLY SEATED ON THE GNS II CMT TIB SIZE 3 RIGHT (WHICH MIGHT HAVE BEEN DAMAGED AT SOME POINT). THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. SOFT TISSUES THAT MAY HAVE BEEN INTERFERING WITH THE LOCKING MECHANISM WERE REMOVED. A GENESIS II CONSTRAINED ARTICULAR INSERT SIZE 3-4 11MM WAS IMPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13636370 ↗
• InjuryMar 1, 2022Adverse 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 ON (B)(6) 2022, IT WAS NOTICED THAT A GNS II CMT TIB SIZE 3 RIGHT WAS IMPLANTED BY ERROR. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022, IN WHICH THE GNS II CMT TIB SIZE 3 RIGHT WAS EXPLANTED AND CHANGED FOR A JOURNEY II. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636293 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON THE (B)(6) 2022 DUE TO AN INFECTION. THE GNS II CMT TIB SIZE 3 RIGHT WAS REPLACED WITH A CEMENT SPACER. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13497643 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT EXPERIENCED TIBIAL COLLAPSE AND FEMUR LOOSENING DUE TO AN INFECTION THIS ADVERSE EVENT LED TO A REVISION SURGERY IN WHICH THREE (3) COMPONENTS, A GII NONPOROUS PS FEM SZ 4 RT, A GNS II CMT TIB SIZE 3 RIGHT AND A LGN PS HIGH FLEX XLPE SZ 3-4 11MM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12550933 ↗
• InjuryMay 21, 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 17 YEARS AGO USING A GNS II CMT TIB SIZE 3 RIGHT, A GNS II RESURF PAT 32MM AND THE GII PS HI FLEX ISRT SZ 3-4 9. THE PATIENT HAD A REVISION SURGERY TO REMOVED AND REPLACED THE IMPLANTS ON AN UNKNOWN DATE. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11862894 ↗
• InjuryMar 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT DURING THE TKA PROCEDURE, AFTER THE TIBIA AND FEMUR IMPLANTATION, THE SURGEON WAS TRYING TO INSERT THE GNS II CMT TIB SIZE 3 RIGHT. THE GNS II CMT TIB SIZE 3 RIGHT WAS PUT IN THE TIBIAL COMPONENT AND UNEXPECTEDLY THE TIBIAL BASEPLATE WAS NOT STABLE. THE FEMORAL COMPONENT WAS STABLE. THE SAME CEMENT HAS BEEN USED FOR THE FEMORAL COMPONENT AND THE TIBIAL BASEPLATE. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11540828 ↗
• MalfunctionMar 16, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING THE TKA PROCEDURE, AFTER THE TIBIA AND FEMUR IMPLANTATION, THE SURGEON WAS TRYING TO INSERT THE LINER. THE LINER WAS PUT IN THE TIBIAL COMPONENT AND THE TIBIAL BASEPLATE WAS NOT STABLE. THE FEMORAL COMPONENT WAS STABLE. THE SAME CEMENT HAS BEEN USED FOR THE FEMORAL COMPONENT AND THE TIBIAL BASEPLATE. THE SURGEON USED A BACKUP SN TIBIAL BASEPLATE TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED. A DELAY OF 30 MIN OR LESS WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495472 ↗
• InjuryDec 29, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA, PATIENT PRESENTED PAIN. A CT SHOWED HOT SPOTS AND LOOSENING ON TIBIAL COMPONENT AND PATELLA. A TOTAL KNEE REVISION SURGERY WAS PERFORMED TO IMPLANT COMPETITOR'S PRODUCTS. PATIENT OUTCOME UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11086810 ↗
• InjuryApr 23, 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 AN INFECTION. ALL THE COMPONENTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9991677 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY PERFORMED ON 2016. IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT FELT AN UNUSUAL SENSATION WHEN STANDING UP FROM A SEATED POSITION, THE JOINT FELT LOOSE AND HAD A CLICKING NOISE. PATIENT KNEE AND LOWER LEG STARTED TO SWELL AND PAIN INCREASED. A SCAN WAS PERFORMED AT (B)(6) HOSPITAL, WHERE THEY DIAGNOSED A BURST BAKERS CYST. IN (B)(6), PATIENT CONTACTED HER SURGEON; A JOINT X-RAY WAS PERFORMED, DOCTOR DIAGNOSED A BROKEN AND DISPLACED INSERT. A REVISION SURGERY WAS PERFORMED TO CORRECT THE ISSUE. DURING THE OPERATION IT WAS DISCOVERED THAT THE POST ON THE INSERT HAD SHEARED OFF AND THE METAL PARTS HAD WORN ON EACH OTHER LEAVING SIGNIFICANT METALLIC DEBRIS AROUND THE JOINT AND METALLOSIS. SINCE THEN, THE SECOND KNEE HAS TAKEN MUCH LONGER TO RECOVER AND PATIENT STILL NEEDS THE AID OF CRUTCHES TO WALK SIGNIFICANT DISTANCES AND REQUIRES THE NIGHTLY USE OF DICLOFENAC 3% GEL.

  Patient problems: Injury

  MAUDE report 9482248 ↗
• MalfunctionSep 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A GEN II TIBIA WAS IMPLANTED WHERE A JOURNEY TIBIA SHOULD HAVE BEEN. NO MORE INFORMATION PROVIDED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9073027 ↗
• InjurySep 15, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS NOTED WITH STIFFNESS POST RIGHT TKR FOR WHICH MANIPULATION UNDER ANESTHESIA WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 9058520 ↗
• InjurySep 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD STIFFNESS AND ARTHROFIBROSIS, AND MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE EVENT.

  Patient problems: Injury; Muscular Rigidity

  MAUDE report 9017446 ↗
• InjuryAug 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED, IT IS UNKNOWN THE REASON FOR THIS REVISION.

  Patient problems: Injury

  MAUDE report 8862833 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO OSTEOLYSIS. ALL IMPLANTS WERE EXCHANGED TO (B)(4) PRODUCTS.

  Patient problems: Injury

  MAUDE report 8704293 ↗
• InjuryJun 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY, AND THE 3 COMPONENTS WERE EXPLANTED DUE TO A SUSPECT INFECTION OF THE IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 8681316 ↗
• InjuryFeb 26, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO 2.5 YEARS SINCE IMPLANTATION OF THE GENESIS II PS PRIMARY KNEE REPLACEMENT. DUE TO THE INSERT PS PEG HAVING FRACTURED AND THE WHOLE POLYETHYLENE HAVING DISLOCATED THE FEMORAL COMPONENT WAS ARTICULATING ON THE TIBIA AND ERODED THE MEDIAL FEMORAL CONDYLE OF THE OXINIUM TKR COMPONENT. THE PATIENT REQUIRED A REVISION PROCEDURE TO A LEGION REVISION PROSTHESIS, MAINTAINING THE PATELLA. DURING THE REVISION PROCEDURE, IT WAS DISCOVERED THE PS POST ON THE PRIMARY INSERT HAD BROKEN AND THE KNEE SUBLUXED POSTERIORLY, WHICH IS THOUGHT TO HAVE CAUSED THE DISLOCATION OF THE INSERT FROM THE TIBIAL BASEPLATE. THE KNEE WAS X-RAYED AND SHOWN TO BE WELL LOCATED AT FOLLOW-UP OF 12-18 MONTHS FOLLOWING THE PRIMARY PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 8370340 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT KNEE CLOSED MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO THE PATIENT DUE TO ARTHROFIBROSIS, STATUS POST TOTAL KNEE ARTHROPLASTY.

  Patient problems: Fibrosis; Injury

  MAUDE report 8205227 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED WITH ERYTHEMA SWELLING SUPRAPATELLAR AREA FOR 2 WEEKS. SHE WAS COMPLAINED OF PAIN DUE TO CELLULITIS. THE PATIENT HAD PAIN STIFFNESS AND FAILED POST ATTEMPTS AND MANIPULATION OF THE RIGHT KNEE. SHE WAS ADMITTED FOR IV VANCOMYCIN ADMINISTRATION FOR SUSPECTED DEEP JOINT PROSTHETIC INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8205225 ↗
• InjuryDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO PAIN. THE RIGHT TIBIAL BASEPLATE AND THE PS TIBIAL INSERT WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 8197564 ↗
• InjuryDec 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN ASPIRATION PERFORMED DUE TO PAIN.

  Patient problems: Injury

  MAUDE report 8187503 ↗
• InjuryDec 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ASPIRATION WAS PERFORMED FOR CELL COUNT DUE TO PAIN.

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 8187401 ↗

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