GENESIS II 71421508Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 03596010492357), received between Nov 14, 2017 and Sep 17, 2025 — classified as 37 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

6 other recalls cover devices cleared under the same FDA submission (K032295); 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING TKA SURGERY, THE TIBIAL AND FEMORAL PROSTHESES WERE COATED WITH BONE CEMENT AND PLACED IN THE USUAL MANNER. A TRIAL INSERT WAS THEN USED. AFTER THE BONE CEMENT HAD SET, ANTERIOR TIBIAL DISLOCATION WAS PERFORMED TO PREPARE FOR THE INSERTION OF THE GII PS HI FLEX ISRT SZ 3-4 9, IT WAS PLACED INTO THE TIBIAL TRAY SLOT AND TAPPED TO LOCK IT IN PLACE. HOWEVER, DURING THE REPOSITIONING OF THE FEMORAL PROSTHESIS, THE GII PS HI FLEX ISRT SZ 3-4 9 DISLODGED, INDICATING A FAILURE IN THE LOCKING MECHANISM. SUBSEQUENT ATTEMPTS TO REPOSITION THE INSERT FAILED TO SECURE IT ONTO THE TIBIAL PROSTHESIS. THE PROCEDURE WAS COMPLETED AFTER A DELAY GREATER THAN 30 MINUTES USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075183 ↗
• MalfunctionJun 11, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA, WHEN THE GII PS HI FLEX ISRT SZ 3-4 9 WAS IMPLANTED, THERE WAS NO FOREIGN BODY IN THE TIBIAL PLATFORM, AND THERE WAS ALWAYS A 1MM GAP BETWEEN THE INSIDE OF THE INSERT AND THE PLATFORM. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MIN, WITH A BIGGER SIZE BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191211 ↗
• MalfunctionAug 29, 2024Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN UNPACKING AND TAKING OUT ONE (1) GII PS HI FLEX ISRT SZ 3-4 9, IT WAS FOUND THAT THE REAR SLOT WAS DEFORMED. THE ATTEMPT TO INSTALL IT INTO THE TIBIAL BASEPLATE FAILED, AND THE SLOT COULD NOT BE INSERTED. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT DELAY OF MORE THAN 30 MINUTES, WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20103102 ↗
• MalfunctionAug 22, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING PRE TKA SURGERY INSPECTION THE OUTER PACKAGING OF A GII PS HI FLEX ISRT SZ 3-4 9 WAS FOUND THE TO BE INTACT AND WITHOUT ISSUES. DURING SURGERY, AFTER OPENING THE OUTER PACKAGING, IT WAS DISCOVERED THAT THE PLASTIC SHELL OF THE INNER PACKAGING WAS NOT PROPERLY SEALED, ALTHOUGH THE INNERMOST PLASTIC SEALING WAS INTACT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 20044821 ↗
• InjuryJun 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, IT WAS NOTICED THAT ONE (1) GII PS HI FLEX ISRT SZ 3-4 9 HAD A BROKEN POST. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH DEVICE WAS REPLACED. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19601812 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION ON THE LEFT KNEE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT, IN WHICH A WASHOUT AND DEBRIDEMENT OF THE SEPTIC LEGION KNEE REPLACEMENT WAS PERFORMED, AS WELL AS A POLY INSERT EXCHANGE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOW.

  Patient problems: Unspecified Infection

  MAUDE report 19255100 ↗
• InjuryDec 22, 2023Adverse 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) 2016, THE PATIENT EXPERIENCED ACUTE SEPTIC ARTHRITIS ON (B)(6) 2023. THIS ADVERSE EVENT WAS TREATED BY WASHOUT, DEBRIDEMENT AND A GII PS HI FLEX ISRT SZ 3-4 9 EXCHANGE ON (B)(6) 2023. HEALTH STATUS OF THE PATIENT IS RECOVERING.

  Patient problems: Arthritis; Medical device site infection

  MAUDE report 18387780 ↗
• InjuryNov 20, 2023Adverse 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 AD UNKNOWN, A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE, IN WHICH THE GII PS HI FLEX ISRT SZ 3-4 9 WAS REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18171573 ↗
• InjuryAug 22, 2023Migration; Migration

  IT WAS REPORTED THAT, AFTER TKA HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED MOBILIZATION OF THE GII PS HI FLEX ISRT SZ 3-4 9. A REVISION SURGERY WAS PERFORMED ON (B)(6)2023 TO ADDRESS THIS EVENT. NO WEAR OF THE IMPLANT WAS OBSERVED, AND NOT REVISION OF ADDITIONAL PROSTHETIC COMPONENTS WAS NEEDED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17598889 ↗
• InjuryAug 2, 2023Migration; Migration

  IT WAS REPORTED THAT AFTER A JOINT REPLACEMENT SURGERY DUE TO BILATERAL KNEE OSTEOARTHROPATHY AND LIMITED MOTION A RIGHT ARTIFICIAL SURFACE TOTAL KNEE ARTHROPLASTY SURGERY WAS PERFORMED ON (B)(6) 2022 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022 FOR POSTOPERATIVE WOUND HEALING. THE PATIENT HAD AN X-RAY TAKEN ON (B)(6) 2023 DUE TO PAIN IN THE RIGHT KNEE AND THE GII PS HI FLEX ISRT SZ 3-4 9 WAS FOUND TO BE DISPLACED. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY PERFORMED ON (B)(6) 2023. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Arthralgia; Joint Laxity

  MAUDE report 17439919 ↗
• InjuryAug 1, 2023Adverse 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) 2015, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A GII PS HI FLEX ISRT SZ 3-4 9 WAS UNSIZED AND EXCHANGED TO A 11MM INSERT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17438682 ↗
• InjuryJul 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED APPROXIMATELY ON 2008, THE PATIENT EXPERIENCED A POST BREAKAGE OF THE GII PS HI FLEX ISRT SZ 3-4 9. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6)2023. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17347732 ↗
• InjuryJun 12, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT, AFTER A TKA SURGERY DONE 12 YEARS AGO, PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 DUE TO UNCLEAR CIRCUMSTANCES. DURING THIS REVISION, A GII PS HI FLEX ISRT SZ 3-4 9 WAS EXPLANTED. DURING THE PROCEDURE IT WAS NOTICED THAT THE LATERAL COMPARTMENT WAS OPEN WHILE THE MEDIAL COMPARTMENT WAS TIGHT. NO PATELLA. THE EXPLANTED INSERT PRESENTED MEDIAL WEAR AND DELAMINATION, WITH THE POST ALSO BEING ROUNDED ON THE MEDIAL SIDE. AN EXTERNAL ROTATION OF THE TIBIAL COMPONENT WAS DONE ALONG WITH RESURFACING OF THE PATELLA. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE AFTER A SIGNIFICANT DELAY. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17114099 ↗
• InjuryMar 15, 2023Break; Break

  IT WAS REPORTED THAT, A REVISION SURGERY HAD TO BE DONE ON (B)(6) 2023, AFTER A GII PS HI FLEX ISRT SZ 3-4 9 WAS ORIGINALLY IMPLANTED ON (B)(6) 2009, BECAUSE THE POST OF THE IMPLANT SNAPPED OFF, AND THE PATIENT FELT INSTABILITY AND CLUNKING IN THE KNEE. DURING THE REVISION SURGERY ONLY THE INSERT WAS EXCHANGED, SINCE ALL THE OTHER IMPLANTS WERE STILL SOLIDLY FIXED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 16547095 ↗
• InjuryDec 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING PROCEDURE, THE POLY OF (1) GII PS HI FLEX ISRT SZ 3-4 9 BROKE INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY DELAY. PATIENT´S CURRENT HEALTH STATUS IS UNKNOWN.

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

  MAUDE report 16067132 ↗
• InjurySep 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON 2006, THE POST OF A GENESIS II SZ 3-4 9 MM BROKE. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO REPLACE FOR A LEGION PS XLPE HIGH FLEX SZ 3-4 11 MM INSERT. THE CURRENT PATIENT CONDITION IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 15475755 ↗
• MalfunctionJul 20, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT SIZE 3-4 9MM COULD NOT BE LOCKED AND FIXED WITH THE TIBIAL BASEPLATE. SURGERY WAS RESUMED, AFTER A 40 MINUTES DELAY, WITH A BACKUP INSERT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15068857 ↗
• 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 HAD BEEN PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED AN TRUNNION FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2021 WHERE A NEW PE INLAY WAS INSERTED. CURRENT HEALTH STATUS OF PATIENT IS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 12551068 ↗
• InjurySep 24, 2021Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2011, THE PATIENT WAS COMPLAINING OF AN UNSTABLE KNEE AND A/P INSTABILITY WAS NOTED. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED AND IT WAS FOUND THAT THE GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT SIZE 3-4 9 MM (-1) WAS DISENGAGED FROM THE LOCKING MECHANISM ON THE UNKNOWN GENESIS II TOTAL KNEE TIBIAL BASEPLATE (-2). BOTH DEVICES PRESENTED SEVERE WEAR ON THE POSTERIOR ASPECT. CURRENT HEALTH STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 12529674 ↗
• MalfunctionJun 16, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOT POSSIBLE TO INSERT THE INNER SIDE OF THE GII PS HI FLEX ISRT SZ 3-4 9, AND IT WAS NOT POSSIBLE TO IMPLANTED NORMALLY. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE AFTER A SIGNIFICANT DELAY (60+ MINUTES). THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012438 ↗
• MalfunctionMay 31, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING SURGERY, WHEN INSTALLING A GII PS HI FLEX ISRT SZ 3-4 9, IT WAS UNSTABLE. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11908615 ↗
• 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 11862966 ↗
• InjuryApr 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON LITERATURE REVIEW "RECURRENT DISSOCIATION OF THE TIBIAL INSERT AFTER MINI-SUBVASTUS POSTERIOR-STABILIZED TOTAL KNEE ARTHROPLASTY: A CASE REPORT. AUTHOR: YONG IN¿, 1 PATIENT PRESENTED DISSOCIATION OF THE TIBIAL INSERT WITHOUT LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS CAUSING A REVISION SURGERY, SAME PATIENT HAD A DISSOCIATION OF THE NEW TIBIAL INSERT CAUSING A 2ND REVISION SURGERY, BOTH COMPLICATIONS WERE PRESENTED WHILE USING GENESIS II TKA SYSTEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11736158 ↗
• InjuryApr 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON LITERATURE REVIEW "RECURRENT DISSOCIATION OF THE TIBIAL INSERT AFTER MINI-SUBVASTUS POSTERIOR-STABILIZED TOTAL KNEE ARTHROPLASTY: A CASE REPORT. AUTHOR: YONG IN¿, 1 PATIENT PRESENTED DISSOCIATION OF THE TIBIAL INSERT WITHOUT LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS CAUSING A REVISION SURGERY, SAME PATIENT HAD A DISSOCIATION OF THE NEW TIBIAL INSERT CAUSING A 2ND REVISION SURGERY, BOTH COMPLICATIONS WERE PRESENTED WHILE USING GENESIS II TKA SYSTEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation

  MAUDE report 11736157 ↗
• MalfunctionApr 2, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PRIMARY TKA SURGERY, THE GII PS HI FLEX ISRT SZ 3-4 9 COULD NOT BE DRIVEN INTO THE ANTEROLATERAL LOCKING MECHANISM SLOT OF THE TIBIAL BASEPLATE DURING INSTALLATION. AFTER REPEATED CLEANING OF THE ANTERIOR AND POSTERIOR LOCKING MECHANISM SLOT OF THE TIBIAL BASEPLATE AND THE SURROUNDING SOFT TISSUES, COMPLETE LOCKING COULD NOT BE PERFORMED EVENTUALLY. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610573 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032295. One submission often covers many models, so check the product and lot details in each record.

• Z-0444-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0449-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0445-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0446-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0447-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0448-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic