GENESIS II 71421510Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010492920), received between Aug 10, 2017 and May 1, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY, THAT HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED A BROKEN POST. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A GII PS HI FLEX ISRT SZ 3-4 13 WAS EXPLANTED. THE CURRENT HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25061908 ↗
• InjuryOct 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED IN (B)(6) 2023, DURING WHICH A GNS II CMT TIB SIZE 4 LEFT, A LEGION PS FEMUR, AND A GII PS HI FLEX ISRT SZ 3-4 13 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 20471183 ↗
• MalfunctionMar 21, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII PS HI FLEX ISRT SZ 3-4 13 (BACK-UP) WOULD NOT SEAT INTO TIBIA TRAY AFTER MULTIPLE ATTEMPTS. A A BACK-UP INSERT WAS OPENED AND FINALLY SEATED. SURGEON HAS HAD MULTIPLE INSTANCES OF THIS OCCURRING WITH PS HIGH FLEXION INSERTS, AND IS DIS-SATISFIED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH 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 18950026 ↗
• MalfunctionMar 17, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII PS HI FLEX ISRT SZ 3-4 13 WOULD NOT SEAT INTO TIBIA TRAY AFTER MULTIPLE ATTEMPTS, A BACK-UP INSERT WAS OPENED AND WOULD NOT SEAT AS WELL. A THIRD INSERT WAS OPENED AND FINALLY SEATED. SURGEON HAS HAD MULTIPLE INSTANCES OF THIS OCCURRING WITH PS HIGH FLEXION INSERTS, AND IS DIS-SATISFIED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH 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 18919095 ↗
• InjurySep 23, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT EXPERIENCED A GNS II POROUS P/S FEM SZ4 LT AND A GNS II CMT TIB SIZE 3 LEFT LOOSENING. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021 IN WHICH METALOSIS WAS OBSERVED AND POLYETHYLENE SHOWED VERY LITTLE SIGNS OF WEAR. IN ADDITION IT WAS DISCOVERED THAT THE NATIVE PATELLA HAD WORN ON THE TROCHLEAR GROOVE OF THE FEMORAL IMPLANT, RELEASING METAL DEBRIS INTO THE JOINT. THE GNS II POROUS P/S FEM SZ4 LT, THE GNS II CMT TIB SIZE 3 LEFT AND THE GNS II CMT TIB SIZE 3 LEFT WERE EXPLANTED IN THE REVISION SURGERY. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 12523449 ↗
• InjuryJun 16, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TKA SURGERY, DURING THE FINAL IMPLANTATION, THE GII PS HI FLEX ISRT SZ 3-4 13 DID NOT LOCK WITH THE TIBIAL TRAY. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011147 ↗
• InjuryAug 31, 2020Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN POST OF THE BASE OF THE POLY. THIS POLY WAS ORIGINALLY IMPLANTED ON (B)(6) 2008. ANOTHER S&N IMPLANT WAS USED.

  Patient problems: Failure of Implant; Injury; Joint Laxity

  MAUDE report 10472023 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA REVISION SURGERY, THE PATIENT FELL ON THE KNEE. A REVISION SURGERY WAS PERFORMED TO TREAT THE RESULTING PATELLAR TENDINITIS. THE GENESIS II PS HIGH FLEXION INSERT, WHICH HAD BROKEN AND DISLODGED, WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 10013356 ↗
• InjuryJan 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED BECAUSE IT WAS SUSPECTED FRACTURE OF THE INSERT AND DISASSOCIATION, BUT THE INSERT WAS NOT FRACTURED AND DISASSOCIATED.

  Patient problems: Injury

  MAUDE report 9615843 ↗
• MalfunctionDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, INSERT COULDN'T BE IMPLANTED. A BACKUP DEVICE FROM SMITH AND NEPHEW WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY GREATER THAN 30 MINUTES BUT NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9400890 ↗
• InjuryAug 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A KNEE REVISION WAS PERFORMED TO REMOVE AND REPLACE INSERT DUE TO PAIN.

  Patient problems: Injury; Pain

  MAUDE report 6784450 ↗

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-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-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
• 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