GENESIS II 71421517Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010492951), received between May 22, 2019 and Dec 26, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2011, THE PATIENT COMPLAINED ABOUT PAIN. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, ON WHICH THE POST OF THE GII PS HI FLEX ISRT SZ 5-6 13 WAS FOUND TO BE BROKEN OFF. THE SURGEON REPLACED THE REPORTED DEVICE WITH A S+N INSERT. NO FURTHER DETAILS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16048693 ↗
• InjuryDec 15, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED JOINT LAXITY DUE TO THE BREAKAGE OF A GII PS HI FLEX ISRT SZ 5-6 13. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021 TO EXPLANT THE DEVICE AND IMPLANT A NEW POLY. IT IS UNKNOWN CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Joint Laxity

  MAUDE report 13010693 ↗
• InjuryDec 10, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A BILATERAL TKA SURGERY HAD BEEN PERFORMED ON 2008, THE PATIENT EXPERIENCED INSTABILITY IN THE LEFT KNEE. A POST OF THE GII PS HI FLEX ISRT SZ 5-6 13 WAS NOTICED TO BE BROKEN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY TO EXPLANT THE POLY AND REPLACE WITH ANOTHER POLY ON (B)(6) 2021. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 12975804 ↗
• InjuryOct 26, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT FELL ABRUPTLY IN HYPER FLEX KNEE AND THE KNEE STARTED FEELING DIFFERENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 IN ORDER TO EXCHANGE THE GII PS HI FLEX ISRT SZ 5-6 13, WHERE THE POST WAS FOUND TO BE BROKEN OFF UPON RETRIEVAL. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Joint Laxity

  MAUDE report 12699339 ↗
• InjuryJan 12, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKR PROCEDURE WAS PERFORMED (B)(6) 2009, THE PATIENT HAD AN ACCIDENT AND DOCTOR BELIEVES HE LANDED ON THE FLEXED KNEE, WHICH FRACTURED THE PS POST ON THE INSERT. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT; ON EXAMINATION, THE POST APPEARED TO HAVE A REASONABLE AMOUNT OF ANTERIOR WEAR. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11155117 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF GEN II WAS PERFORMED DUE TO AN UNSPECIFIED REASON. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11018675 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA A REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASONS, THE GEN II PS ((B)(4)), GEN II BASEPLATE ((B)(4)) AND PS INSERT ((B)(4)) WERE EXPLANTED. NO OTHER COMPLICATIONS WERE 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 11015842 ↗
• InjuryAug 28, 2020Break; Break

  IT WAS REPORTED THAT GENESIS II PS HI FLEX INSERT SIZE 5-6 13 POST BROKE OFF INSIDE OF THE PATIENT 7 YEARS AFTER IMPLANTATION. REVISION SURGERY WAS PERFORMED BUT NO INFORMATION ABOUT THIS PROCEDURE WAS INITIALLY PROVIDED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10463942 ↗
• InjuryOct 1, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE A UNSTABLE KNEE. PATIENT HAD A FALL ON HIS KNEE AND IT WAS DISCOVERED THAT THE INSERT HAD BROKEN OFF.

  Patient problems: Injury

  MAUDE report 9142249 ↗
• InjuryMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE WOUND WAS OOZING BLOODS FIVE DAYS AFTER THE INITIAL OPERATION. CLINICAL PROTOCOL DICTATES THAT THE WOUND HAS TO BE WASHED. POLY WAS REPLACED WITH A NEW ONE. THERE WAS NO ISSUE WITH THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 8633201 ↗

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-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-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