GENESIS II 71421509Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 03596010492364), received between Aug 17, 2017 and Nov 3, 2025 — classified as 20 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2006, THE PATIENT EXPERIENCED DISCOMFORT IN THE LEFT KNEE. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025 REVEALING THAT THE POST PART OF THE INSERT HAD FRACTURED, IN WHICH ONLY THE GII PS HI FLEX ISRT SZ 3-4 11 WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 23460409 ↗
• MalfunctionFeb 6, 2025Positioning Failure; Insufficient Device Problem Information; Positioning Failure; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII PS HI FLEX ISRT SZ 3-4 11 COULDN'T BE IMPLANTED. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACKUP GII PS HI FLEX ISRT SZ 3-4 13, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324801 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON AN UNKNOWN DATE, DURING WHICH A GENESIS II BASEPLATE, A LEGION PS FEMUR, AND A PS-HI-FLEX INSERT WERE PLACED, THE PATIENT EXPERIENCED POLY DISSOCIATION. THE SURGEON STATED THAT THE LOCKING MECHANISM OF THE GENESIS II BASEPLATE IS VERY ROBUST; HOWEVER, HE ENSURED DURING THE SURGERY THAT THE POLY WAS PROPERLY LOCKED IN. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19741649 ↗
• InjurySep 11, 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 AN UNDISCLOSED DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A WASHOUT AND REVISION SURGERY ON (B)(6) 2023, IN WHICH A GII PS HI FLEX ISRT SZ 3-4 11 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 17720871 ↗
• InjuryJan 4, 2023Adverse 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 (B)(6) 2007, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A GII PS HI FLEX ISRT SZ 3-4 11 WAS REPLACED WITH A LEGION INSERT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16092973 ↗
• InjuryOct 19, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED WITH A GENESIS II SYSTEM, THE PATIENT PRESENTED JOINT INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXPLANT THE GII PS HI FLEX ISRT SZ 3-4 11. IT WAS FOUND THAT DURING THE IMPLANTATION SURGERY, WHICH HAD BEEN CONDUCTED ON (B)(6) 2008, SUCH INSERT HAD BEEN IMPLANTED ON A GII CMT TIB SIZE 5 RIGHT: SIZES DID NOT MATCH. IT IS UNKNOWN WHAT THE CURRENT HEALTH STATUS OF PATIENT IS.

  Patient problems: Joint Laxity

  MAUDE report 15635360 ↗
• InjuryJul 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2010 WITH A GENESIS II SYSTEM, THE PATIENT EXPERIENCED INSTABILITY IN THE KNEE FOR A COUPLE OF MONTHS. THIS ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022. UPON INSPECTION, IT WAS NOTICED THAT THE POST WAS BROKEN OFF OF THE GII PS HI FLEX ISRT SZ 3-4 11. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15136589 ↗
• MalfunctionJul 25, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII PS HI FLEX ISRT SZ 3-4 11 COULD NOT BE LOCKED AND FIXED WITH THE TIBIAL BASEPLATE. SURGERY WAS FINISHED WITH A SN BACK-UP 9MM INSERT, AFTER A DELAY GREATER THAN 30 MINUTES. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093752 ↗
• MalfunctionApr 19, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A GENESIS II PS HI FLEX INSERT SIZE 3-4 11MM FAILED TO ATTACH TO THE TIBIAL PLATEAU, EVEN AFTER SEVERAL ATTEMPTS. SURGERY WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140868 ↗
• InjuryOct 11, 2021Break; Break

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT HAD A RECENT FALL AND EXPERIENCED SOME ANTERIOR-POSTERIOR INSTABILITY WITH THE TKR. THIS ADVERSE EVENT WAS SOLVED BY ARTHROSCOPY ON THE KNEE, AND NOTED THE POST ON THE POLY WAS BROKEN, THEN THE KNEE WAS OPEN AND EXCHANGED THE POLY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Joint Laxity

  MAUDE report 12611733 ↗
• InjuryJun 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE POST OF A GII PS HI FLEX ISRT SZ 3-4 11 IMPLANT FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 IN ORDER TO EXCHANGE THE IMPLANT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12087890 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RTKA SURGERY HAD BEEN PERFORMED 10 -12 YEARS AGO, THE PATIENT EXPERIENCED HYPEREXTENSION ISSUE. THE PATIENT HAD A REVISION SURGERY TO EXCHANGE THE GII PS HI FLEX ISRT SZ 3-4 11 FOR GII PS HI FLEX ISRT SZ 3-4 18. THE CONDITION OF THE PATIENT 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 11813264 ↗
• MalfunctionDec 30, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE ARTICULAR INSERT WAS NOT ABLE TO LOCK ON THE TIBIA TRAY. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT 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 11095788 ↗
• InjuryOct 8, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, EVEN WHEN USING TWO DIFFERENT IMPACTORS, IT WAS IMPOSSIBLE TO IMPLANT THE INSERT. PROCEDURE CONTINUED WITH A BACKUP DEVICE, WITH A DELAY OF LESS THAN 30 MINUTES AND WITHOUT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10648219 ↗
• InjuryAug 5, 2020Unstable; Unstable

  IT WAS REPORTED THAT IT WAS REVISED A GEN II TIBIAL BASEPLATE AND POLYETHELENE INSERT FOR ASEPTIC LOOSENING. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10370655 ↗
• InjuryFeb 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A MECHANICAL FALL AT HOME AND WAS FOUND EXTRUSION OF POLYETHYLENE.

  Patient problems: Injury

  MAUDE report 9747393 ↗
• InjuryFeb 14, 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 IN PATIENT WITH PATELLA DEGENERATION DUE TO PATELLA ARTHRITIS. INSERT WAS REPLACED AND THE PATELLA RESURFACED.

  Patient problems: Injury

  MAUDE report 9711279 ↗
• InjuryJan 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED REVISION SURGERY WAS PERFORMED DUE TO POLY DISENGAGED, CAUSED BY FALLING OF THE PATIENT.

  Patient problems: Injury

  MAUDE report 9580233 ↗
• InjuryDec 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR POLY EXCHANGE. DUE TO INSTABILITY. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Injury

  MAUDE report 9431299 ↗
• InjuryFeb 5, 2019Misassembled; Misassembled

  A REVISION SURGERY WAS PERFORMED DUE TO THE POLY CAME OUT OF THE TIBIA CAUSING METAL WEAR.

  Patient problems: Injury

  MAUDE report 8305927 ↗
• 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 8283340 ↗
• InjuryJan 15, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BASEPLATE LOOSENING. BASEPLATE AND INSERT WERE REPLACED.

  Patient problems: Injury

  MAUDE report 8249560 ↗
• InjuryMar 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO HEMATOMA. THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE.

  Patient problems: Injury

  MAUDE report 7325702 ↗
• MalfunctionFeb 10, 2018Fitting Problem; Fitting Problem

  THE INSERT STUCK IN THE BASEPLATE SLOT AND COULDN'T BE IMPLANTED. THEN CHECK THE INSERT FOUND THERE WAS A TUBER ON THE INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7262496 ↗
• InjuryAug 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE POLY.

  Patient problems: Injury; No Information

  MAUDE report 6800415 ↗

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-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
• 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-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-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-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