GENESIS II 71421516Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 03596010492333), received between Nov 21, 2017 and Apr 23, 2026 — classified as 32 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED IN (B)(6) 2007, THE PATIENT EXPERIENCED POST BREAKAGE RENDERING PATIENT'S KNEE UNSTABLE. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE GII PS HI FLEX ISRT SZ 5-6 11 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24974237 ↗
• MalfunctionFeb 3, 2026Positioning Failure

  IT WAS REPORTED THAT, DURING A RIGHT TKA SURGERY, ONE (1) GII PS HI FLEX ISRT SZ 5-6 11 INSERT WAS NOT MATCHING WITH THE TIBIAL PLATEAU AND WAS LOOSE. THE PROCEDURE WAS PERFORMED, AFTER A GREATER THAN 30 MIN DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246705 ↗
• MalfunctionSep 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A RIGHT KNEE JOINT REPLACEMENT SURGERY, THE CIRCULATING NURSE HAS OPENED THE OUTER PACKAGING OF A GII PS HI FLEX ISRT SZ 5-6 11 AND IT WAS NOTICED THAT THE BOX AND THE PAPER-PLASTIC SEAL WERE NOT SEALED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23108048 ↗
• InjuryMay 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED A BREAKAGE OF THE POST OF THE (1) GII PS HI FLEX ISRT SZ 5-6 11. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE (1) GII PS HI FLEX ISRT SZ 5-6 11 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 22120001 ↗
• InjurySep 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED KNEE INSTABILITY AND UNCOMFORTABLENESS AS THE POST OF ONE (1) GII PS HI FLEX ISRT SZ 5-6 11 HAD BROKEN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A NEW PS INSERT WAS IMPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 20286126 ↗
• InjurySep 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED KNEE INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 IN ORDER TO SWAP THE GII PS HI FLEX ISRT SZ 5-6 11 FOR A THICKER INSERT AND FIX THE STABILITY ISSUE. IT WAS NOTICED THAT THE GII PS HI FLEX ISRT SZ 5-6 11 CAME OUT WITH A BROKEN POST. IT WAS REPLACED WITH A 5-6 MM X 15MM PS POLY. THE KNEE WAS CHECKED FOR STABILITY AND SURGEON WAS HAPPY WITH THE CASE. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Joint Laxity

  MAUDE report 20131433 ↗
• InjuryNov 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED IN 2009, THE POST OF THE GII PS HI FLEX ISRT SZ 5-6 11 FAILED . THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A NEW INSERT WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN

  Patient problems: Failure of Implant

  MAUDE report 18076546 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY (LEFT) WAS PERFORMED ON (B)(6) 2006, THE PATIENT HAD AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023,IN WHICH THE SURGEON PERFORMED A WASHOUT AND REPLACED THE GII PS HI FLEX ISRT SZ 5-6 11. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 17950840 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY (RIGHT) WAS PERFORMED ON (B)(6) 2007, THE PATIENT HAD AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE SURGEON PERFORMED A WASHOUT AND REPLACED THE GII PS HI FLEX ISRT SZ 5-6 11. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 17950724 ↗
• InjuryJun 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2008, THE PATIENT EXPERIENCED LAXITY AND TIBIA SUBLUXATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO EXCHANGE THE GII PS HI FLEX ISRT SZ 5-6 11, AND THE POST WAS FOUND TO BE BROKEN. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17242988 ↗
• InjuryJun 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED 15 YEARS AGO, THE PATIENT EXPERIENCED 'CLUNKING' NOISE AND INSTABILITY IN THE KNEE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH IT WAS FOUND THAT THE GII PS HI FLEX ISRT SZ 5-6 11 HAD BEEN SEVERED AND THE IMPLANT WAS IN TWO BITS. THE INSERT WAS REPLACED WITH A NEW CONSTRAINED PS TIBIAL INSERT AND LOCKED INTO PLACE AFTER SOME RANGE OF MOTION. THE KNEE WAS WASHED OUT EXTENSIVELY AND CLOSED UP. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17121919 ↗
• InjuryJun 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED A FRACTURE OF A GII PS HI FLEX ISRT SZ 5-6 11 POST. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2023, WHERE AN INSERT WAS REMOVED, AND A NEW ONE WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17084157 ↗
• InjuryDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A RIGHT KNEE SURGERY WAS PERFORMED ON (B)(6) 2006, THE POST OF THE GII PS HI FLEX ISRT SZ 5-6 11 BROKE DUE TO WEAR. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16048528 ↗
• InjuryDec 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2022, THE GII PS HI FLEX ISRT SZ 5-6 11 BROKE ON POLY. FOR THIS REASON, A REVISION SURGERY WAS CARRIED OUT AND DEVICE WAS EXPLANTED. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15921709 ↗
• InjuryJul 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INITIAL SURGERY WAS PERFORMED ON (B)(6) 2022, THE GII PS HI FLEX ISRT SZ 5-6 11 FRACTURED. A REVISION SURGERY ON THE SAME DATE WAS PERFORMED TO EXPLANT THE DEVICE. FURTHER INFORMATION IS UNKNOWN AT THE MOMENT.

  Patient problems: Failure of Implant

  MAUDE report 15136774 ↗
• InjuryJun 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON 2010, THE PATIENT FELL ON HIS TKA. THE PATIENT PRESENTED WITH PAIN AND INSTABILITY IN THE CLINIC. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THE SURGERY, IT WAS REVEALED THAT THE TOP POST OF THE GII PS HI FLEX ISRT SZ 5-6 11 HAD FRACTURED OFF AND WAS LODGED IN SOFT TISSUE IN THE NOTCH. ALL PIECES WERE SUCCESSFULLY REMOVED AND A NEW PS STANDARD POLY WAS IMPLANTED. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Joint Laxity; Pain

  MAUDE report 14638969 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT WAS HOSPITALIZED DUE TO LEFT KNEE PAIN, LIMITED ACTIVITY AND GRADUAL AGGRAVATION FOR 10 YEARS. THE PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY UNDER GENERAL ANESTHESIA ON (B)(6) 2021. AFTER ONE MONTH ((B)(6) 2021) THE PATIENT WAS RE ADMITTED TO THE HOSPITAL DUE TO POOR LOCAL HEALING OF THE SURGICAL WOUND OF THE LEFT KNEE. ON (B)(6) 2021, HE ACCEPTED THE DEBRIDEMENT AND INSERT REVISION. THE POSTOPERATIVE RECOVERY WAS GOOD. POSTOPERATIVE PERIPROSTHETIC INFECTION. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Impaired Healing; Pain; Unspecified Infection

  MAUDE report 14352725 ↗
• InjuryFeb 16, 2022Break; Break

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON 2007, THE PATIENT EXPERIENCED BREAKAGE OF THE IMPLANTED GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT SIZE 5-6 11MM. THIS HAPPENED ON (B)(6) 2022 WHEN THE PATIENT WAS CROSSING LEGS AND A "POP" SOUND WAS HEARD. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13545748 ↗
• InjuryFeb 15, 2022Break; Break

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ABOUT 10 YEARS AGO, THE GII PS HI FLEX ISRT SZ 5-6 11 BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO SWAP OUT THE DEVICE. PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13537031 ↗
• InjuryMay 6, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKR, THE GII PS HI FLEX ISRT SZ 5-6 11 WAS UNSTABLE IN COMBINATION WITH THE TIBIAL BASEPLATE. AFTER SEVERAL TRIES, THE INSERT WAS REMOVED AND IT WAS FOUND THAT THE GROOVE AT THE BOTTOM WAS UNEVEN AND DID NOT MATCH THE TIBIAL BASEPLATE. IT IS UNKNOWN WHETHER THERE WAS A SIGNIFICANT DELAY ON THE PROCEDURE OR NOT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781905 ↗
• InjuryJan 26, 2021Break; Break

  IT WAS REPORTED THAT, AFTER TKA, POST ON GENESIS II PS HIGH FLEX INSERT SIZE 5-6 11 BROKE. A REVISION SURGERY WAS PERFORMED, POST WAS FOUND IN THE NOTCH AND METALLOSIS WAS NOTICED IN THE KNEE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 11229827 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Arthralgia; Fibrosis; Medical device site infection; Osteolysis; Unspecified Infection

  MAUDE report 11106319 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE TKA PROCEDURE THAT THE PATIENT PRESENTED OF KNEE INSTABILITY, THEREFORE THE SURGEON HAD TO REPLACE THE INSERT WITH ANOTHER CONSTRAINED 13MM INSERT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY WAS REPORTED AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002097 ↗
• InjuryDec 9, 2020Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE POST OF A GII PS HI FLEX ISRT SZ 5-6 11 BROKE. A REVISION SURGERY WAS PERFORMED TO ADDRESS THIS ADVERSE EVENT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10979403 ↗
• MalfunctionNov 19, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING SURGERY IT WAS NOTICED THAT THE DOCTOR COULDN'T GET THE INSERT TO SIT SECURELY INTO THE TIBIAL BASE PLATE. A SECOND INSERT OF THE SAME SIZE AND THICKNESS WAS OPENED AND WENT IN WITH NO PROBLEM. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10872099 ↗

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-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
• 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-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
• 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