GENESIS II 71421501Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010492388), received between Jun 5, 2018 and Apr 10, 2025 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) GII PS HI FLEX ISRT SZ 1-2 9 MM COULD NOT BE TIGHTENED. THE DEVICE DID NOT HAVE ANY INADEQUACY OF SHAPE OR SIZE. FINALLY, THE GASKET OF THE SAME TYPE WAS REPLACED AND IMPLANTED SMOOTHLY. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE OF THE SAME SIZE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21813581 ↗
• InjuryMar 12, 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 UNKNOW DATE, THE PATIENT EXPERIENCED INSTABILITY ON THE KNEE DUE TO AN UNSIZED POLY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18888314 ↗
• MalfunctionApr 27, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) GII PS HI FLEX ISRT SZ 1-2 9 WOULD NOT LOCK WITH THE TIBIAL BASEPLATE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825641 ↗
• InjuryAug 17, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING TKA SURGERY, GENESIS II PS HI FLEX INSERT SIZE 1-2 9 MM FAILED TO LOCK INTO TIBIA, EVEN AFTER MANY ATTEMPTS. THE SURGERY WAS COMPLETED USING INSERT SIZE 1-2 11 MM THE TIBIA WAS AMPUTATED BY TWO MILLIMETERS, SO THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING AN S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246107 ↗
• InjuryMay 24, 2022Material Erosion; Fracture; Adverse Event Without Identified Device or Use Problem; Material Erosion; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON THE (B)(6) 2008, THE SURGEON STATED THAT THE TOTAL KNEE REPLACEMENT WAS A FAILURE. THE PATIENT IS EXPERIENCING INCREASING PAIN IN THE RIGHT KNEE. THE PATIENT FEELS PAIN WHEN WALKING OR LYING DOWN. THE PATIENT STATES THAT THE KNEE ALSO "BUCKLES" TO THE OUTSIDE OF THE LEG WHILE WALKING AND THE KNEE FEELS LOOSE AND WOBBLY FROM SIDE TO SIDE. AS NOTICED IN THE X-RAY, THE INSERT HAS TOTALLY FAILED AND IS GONE. THE PATIENT HAS NOT RECEIVED TREATMENT OR MEDICAL INTERVENTION. THE SITUATION IS ONGOING.

  Patient problems: Discomfort; Failure of Implant; Infiltration into Tissue; Pain

  MAUDE report 14490075 ↗
• InjuryNov 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD INLAY DISLOCATION. THE PE INLAY CAN NO LONGER BE SUFFICIENTLY REFIXED TO THE TIBIA WITH THE PS MECHANISM. DECOUPLING THE POLYETHYLENE.

  Patient problems: Injury

  MAUDE report 9268905 ↗
• InjuryNov 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN. THE POLY WAS EXCHANGED AND THE PATELLA REVISED, SURGEON STATED THE PATELLA WAS LOOSE.

  Patient problems: Injury

  MAUDE report 8101377 ↗
• InjuryOct 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED DURING A LITERATURE REVIEW, AFTER FIRST REVISION SURGERY FROM COMPLAINT (B)(4) , ONE MONTH FOLLOWING THE REVISION THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION SECONDARY TO A (B)(4), WHICH ULTIMATELY REQUIRED A TWO-STAGE REVISION SURGERY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7996288 ↗
• InjuryOct 23, 2018Material Separation; Material Separation

  IT WAS REPORTED DURING A LITERATURE REVIEW, THAT AT 32 WEEKS OF PRIMARY SURGERY THE PATIENT COMPLAINED OF A SUDDEN ONSET OF KNEE PAIN ASSOCIATED WITH RESTRICTED RANGE OF MOTION. DURING PHYSICAL EXAMINATION, AN AUDIBLE POPPING SOUND WAS EMANATED FROM A SWOLLEN RIGHT KNEE. THE PATIENT REFERRED THAT A WEEK EARLIER HE HAD SUFFERED A HALF-METER FALL FROM A BUS WITH BOTH KNEES HELD IN SEMIFLEXION.

  Patient problems: Injury

  MAUDE report 7996030 ↗
• InjuryOct 23, 2018Material Separation; Material Separation

  IT WAS REPORTED FROM A LITERATURE REVIEW, THAT THE PATIENT RETURNED TO THE HOSPITAL 14 MONTHS AFTER THE PRIMARY SURGERY. THE INSERT WAS FOUND DISLOCATED AND A REVISION SURGERY WAS PERFORMED DUE TO THIS.

  Patient problems: Injury

  MAUDE report 7994985 ↗
• InjuryOct 23, 2018Noise, Audible; Noise, Audible

  IT WAS REPORTED DURING A LITERATURE REVIEW, 33 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED A CLICKING SENSATION IN HER LEFT KNEE AFTER A LOUD POPPING SOUND WAS HEARD WHEN STANDING UP FROM SITTING.

  Patient problems: Injury

  MAUDE report 7994983 ↗
• InjuryOct 22, 2018Material Separation; Material Separation

  IT WAS REPORTED A SPONTANEOUS LATE DISASSOCIATION OF THE TIBIAL INSERT TWO YEARS AND A HALF POSTOPERATIVELY, THE PATIENT COMPLAINED OF SUDDEN ONSITE RIGHT KNEE PAIN THAT HAD LASTED FOR ONE MONTH. THIS INFORMATION WAS IDENTIFIED DURING A LITERATURE REVIEW

  Patient problems: Pain

  MAUDE report 7993399 ↗
• InjuryOct 22, 2018Material Separation; Material Separation

  IT WAS REPORTED DURING A LITERATURE REVIEW A TRAUMATIC LATE DISSOCIATION OF THE POLYETHYLENE INSERT WITH THE PATELLAR TENDON RUPTURE AFTER THE TKA. 2 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT COMPLAINED OF SUDDEN ONSET KNEE PAIN WITH RESTRICTED MOTION AFTER FALL AT HOME.

  Patient problems: Injury; Pain

  MAUDE report 7993353 ↗
• InjuryJun 5, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 7569904 ↗

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-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-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-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-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