GENESIS II 71421522Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010492975), received between May 22, 2018 and Nov 25, 2025 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 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.

• InjuryNov 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A BROKEN POST. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE GII PS HI FLEX ISRT SZ 7-8 9 WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23646930 ↗
• InjuryMar 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO THE POST OF ONE (1) GII PS HI FLEX ISRT SZ 7-8 9 BEING BROKEN. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21590096 ↗
• InjuryJan 8, 2025Adverse 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, THE PATIENT EXPERIENCED AN INFECTED KNEE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A GII PS HI FLEX ISRT SZ 7-8 9 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21102050 ↗
• InjuryNov 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A KNEE REVISION SURGERY HAD BEEN PERFORMED 17 YEARS AGO, THE PATIENT EXPERIENCED ARTHRITIC CHANGES IN THE PATELLOFEMORAL JOINT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024 WERE THE GII PS HI FLEX ISRT SZ 7-8 9 WAS EXCHANGED AND THE PATELLA WAS RESURFACED. ADDITIONALLY, THE POLYETHYLENE COMPONENT SHOWED MINOR WEAR, LEADING TO A NEW POLYETHYLENE. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Arthritis

  MAUDE report 20674086 ↗
• InjuryAug 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE SURGEON DISCOVERED POSTERIOR STABILIZED POST TO BE BROKEN. THE PATIENT REPORTED INSTABILITY OF THE JOINT AS A CONSEQUENCE OF THIS ISSUE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE GII PS HI FLEX ISRT SZ 7-8 9 WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 19913198 ↗
• InjuryJun 20, 2023Degraded; Degraded

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 DUE TO WEAR OF THE GII PS HI FLEX ISRT SZ 7-8 9. DURING THIS SURGERY THE GII PS HI FLEX ISRT SZ 7-8 9 WAS EXCHANGED. THE CURRENT STATUS OF THE PATIENT IS GOOD.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164060 ↗
• InjuryFeb 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKR SURGERY WAS PERFORMED ON (B)(6) 2009, THE PATIENT FELT A SUDDEN GIVE IN HIS KNEE WHEN GOING UP STAIRS. THIS ADVERSE EVENT WAS TREATED VIA REVISION SURGERY ON (B)(6) 2023, IN WHICH IT WAS NOTICED THAT THE POST OF A GII PS HI FLEX ISRT SZ 7-8 9 HAD BROKEN, SO IT WAS REMOVED AND EXCHANGED FOR A NEW ONE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16450056 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2015, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, DUE TO ANTERIOR PAIN AND KNEE LAXITY, A PATELLAR COMPONENT INSERT WAS IMPLANTED DURING THIS REVISION SURGERY AND THE GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT SIZE 7-8 9MM WAS REPLACED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13458161 ↗
• InjuryJan 14, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A FALL AND THE POST OF THE INSERT BROKE. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE INSERT. THE PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 11168559 ↗
• MalfunctionSep 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, INSERT WOULD NOT CLICK PROPERLY INTO THE BASEPLATE, ON REMOVAL AND AFTER INSPECTION IT WAS SEEN THAT THERE WAS A MALFORMING OF THE UNDERPART OF THE INSERT. PROCEDURE CONCLUDED WITH A DELAY OF FEWER THAN 30 MINUTES AND WITH A BACKUP DEVICE OF THE SAME SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10558332 ↗
• InjuryJun 16, 2020Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A KNEE REVISION SURGERY WAS BOOKED BY THE DOCTOR ON MAY 27. THE X-RAYS SHOWS POSSIBLE BREAKAGE OF PS INSERT POST. PRIMARY SURGERY WAS DONE BY THE SAME SURGEON IN 2008 USING A GENESIS II PS. FOR THIS REVISION THE SURGEON EXCHANGED THE INSERT WHICH WILL BE SEND AS RETRIEVED IMPLANT. THE PS INSERT PEG WAS INTACT AND NOT BROKEN AS EXPECTED FROM X-RAY AND CLINICAL EXAMINATION. THE TIBIA WAS SUBLUXED POSTERIORLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Injury; Subluxation

  MAUDE report 10160529 ↗
• MalfunctionJun 16, 2020Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT, DURING IMPLANTING, THE OUTER SIDE OF THE INSERT COULD NOT BE LOCKED. AFTER TAKING IT OFF, THE SURGEON CLEANED IT AND CHECKED IT. AFTER THREE TIMES OF INSTALLATION, THE SURGERY WAS DELAYED. LATER, A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10159573 ↗
• InjuryJun 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY OF TKA WAS PERFORMED DUE TO FRACTURE AT THE POST OF THE GENESIS II SIZE 7-8 9MM PS HIFLEX INSERT. THE CAUSE OF THE IMPLANT FRACTURE IS UNKNOWN AND SO IS THE PATIENT OUTCOME.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10127275 ↗
• InjuryJan 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A POST BROKE ON INSERT WHEN PATIENT WAS KNEELING IN THE GARDEN AND THEN STOOD UP.

  Patient problems: Injury

  MAUDE report 9631681 ↗
• InjuryJan 17, 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 LOOSENING, OSTEOLYSIS AND POSSIBLE CHANCE OF INFECTION. OSTEOLYSIS WAS CONFIRMED INTRAOPERATORY BY THE SURGEON. ALL COMPONENTS WERE REPLACED WITH CEMENT SPACERS. PRIMARY SURGERY PERFORMED ON (B)(6) 2012.

  Patient problems: Injury

  MAUDE report 9603217 ↗
• InjuryJul 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2012 A TKA PROCEDURE WAS PERFORMED. PATIENT EXPERIENCE POST-OPERATIVE STIFFNESS AND A MUA WAS PERFORMED TO CORRECT THE ISSUE. SLOWLY STIFFNESS RETURNED AND A REVISION SURGERY WAS REQUIRED TO INCREASE ROM MAINLY INTO FLEXIBILITY. SURGEON ATTRIBUTED STIFFNESS TO SCARRING AND PATELLA MALTRACKING. A SCAR WAS PERFORMED TO RELEASE, POLY EXCHANGE AND REVISED PATELLA. ROM IMPROVED POST-OPERATIVE.

  Patient problems: Injury

  MAUDE report 8787728 ↗
• InjuryMay 9, 2019Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND APPARENT PS POST FRACTURE OF INSERT.

  Patient problems: Pain

  MAUDE report 8597474 ↗
• InjuryApr 7, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INSERT THAT SNAPPED OFF. DEVICE WILL NOT BE RETURN.

  Patient problems: Injury

  MAUDE report 8489938 ↗
• InjuryFeb 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO SEPSIS PRESENT. ALL IMPLANTS WERE REMOVED. ALSO, A WASHOUT WAS DONE AND A CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 8371931 ↗
• InjuryDec 20, 2018Break; Break

  IT WAS REPORTED A REVISION SURGERY FOR A POSSIBLE TIBIAL LOOSENING, HOWEVER, THE SURGEON DISCOVERED THE POST FROM THE ARTICULAR INSERT HAD BROKEN. THE BROKEN PART WAS LODGED IN THE FEMORAL NOTCH. SURGEON CHOSE TO EXCHANGE THE LINER ONLY.

  Patient problems: Injury

  MAUDE report 8184377 ↗
• InjurySep 29, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATED PATELLA IMPLANT REVISED: SWAPPED A GENESIS II 7-8 9MM POLY TO A LEGION 7-8 9MM POLY. ORIGINAL POLY EXHIBITED NO SIGNS OF WEAR OR DAMAGE, AND WAS SWAPPED OUT JUST AS AN INFECTION CONTROL PRECAUTION.

  Patient problems: No Information

  MAUDE report 7921058 ↗
• InjuryJun 2, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE INSERT COULD BE PUT INTO THE PATIENT BUT COULDN'T LOCK TIGHTLY, WHEN BENDED THE PATIENT KNEE, IT WOULD BE DISLOCATED. THE SURGICAL TIME WAS EXTENDED FOR 40 MINUTES.

  Patient problems: No Information

  MAUDE report 7563996 ↗
• InjuryMay 22, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WENT TO SURGERY FOR A POLY SWAP. WHEN THE SURGEON OPEN THE KNEE, HE REALISED THAT THE POSTERIOR SIDE OF THE POLY POST WAS CLEARLY DAMAGE. HE COULD EASILY FLEX THE POST. HE THEN REMOVED THE WORN OUT POLY, AND REPLACE IT BY A BRAND NEW ONE.

  Patient problems: Injury

  MAUDE report 7533710 ↗

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-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-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-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-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-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