GENESIS II 71430415Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03596010493057), received between Feb 27, 2019 and Feb 7, 2024 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Flaked; Material Fragmentation; Deformation Due to Compressive Stress; Flaked; Material Fragmentation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE GII PS HI FLEX ISRT TR S5-6 9 WAS WORN AND CHIPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660078 ↗
• MalfunctionSep 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE FRONT EDGE OF A GII PS HI FLEX ISRT TR S5-6 9 GOT CHIPPED OFF. THE PIECE CHIPPED OFF WHEN THEY TRIED TO REMOVE THE TRIAL WHEN IT WAS IN THE PATIENT. THE CHIPPED PIECE STAYED ATTACHED TO THE KOCHER, SURGEON GRABBED IT WITH SO IT DIDN'T FALL IN THE PATIENT. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH THE SAME DEVICE SINCE THEY TOOK THE TRIAL OUT AND THEY WERE READY TO CEMENT SO DIDN'T HAVE TO USE IT AGAIN. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741927 ↗
• MalfunctionAug 8, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AT THE TIME OF PLACING A GII PS HI FLEX ISRT TR S5-6 9, IT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484039 ↗
• MalfunctionJan 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, WHILE IMPUTING, A GII PS HI FLEX ISRT TR S5-6 9 BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091398 ↗
• MalfunctionSep 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT, WHILE INSPECTING INSTRUMENTS, IT WAS NOTICED THAT A GII PS HI FLEX ISRT TR S5-6 9 IS BADLY CHIPPED. AS NO CASE WAS INVOLVED, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434717 ↗
• MalfunctionSep 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING INSPECTION, A GII PS HI FLEX ISRT TR S5-6 9 WAS FOUND BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434688 ↗
• MalfunctionSep 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING INSPECTION, A GII PS HI FLEX ISRT TR S5-6 9 WAS FOUND BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434677 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, A GII PS HI FLEX ISRT TR S5-6 9 WAS BROKEN. NO PATIENT WAS INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393691 ↗
• MalfunctionJul 23, 2022Break; Break

  IT WAS REPORTED THAT, A GII PS HI FLEX ISRT TR S5-6 9 BROKE WHEN GOING THROUGH THE WASH. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090391 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S5-6 9 IS FLAKING AND CHIPPING. IT IS UNKNOWN WHEN THIS WAS NOTICED AND IF THERE WAS A PATIENT INVOLVED. 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 14672401 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S5-6 9 IS FLAKING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT. 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 14672335 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S5-6 9 IS FLAKING AND CHIPPING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT. 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 14671762 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S5-6 9 IS FLAKING AND CHIPPING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT. 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 14671556 ↗
• MalfunctionSep 14, 2021Flaked; Naturally Worn; Flaked; Naturally Worn

  IT WAS REPORTED THAT A GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 5-6 9MM IS CHIPPED AND WORN OUT. AS THIS WAS NOTICED IN A WAREHOUSE UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468924 ↗
• MalfunctionAug 16, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 1-2 9 MM, ONE (1) ECHELON 260 MM POROUS BOWED FEMORAL COMPONENT STANDARD COLLAR SIZE 16 LEFT, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 7-8 9 MM, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 7-8 11 MM, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 5-6 9 MM AND ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 3-4 11 MM ARE CRACKED AND WORN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325097 ↗
• MalfunctionJun 9, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT 4 CONSTRAINED INSERT TRIALS, 4 ARTICULAR INSERT SPACER TRIALS, 4 POSTERIOR STABILIZED HIGH FLEXION INSET TRIALS AND 3 POSTERIOR STABILIZING ARTICULAR TRIALS FROM GENESIS II SYSTEM ARE BEING RETURNED FOR REPLACEMENT BECAUSE THEY'RE COVERED IN SCRATCHES, CHIPS AND CRACKS. NO CASE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967781 ↗
• MalfunctionJun 1, 2021Crack; Naturally Worn; Scratched Material; Crack; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT, DURING STERILIZATION PROCEDURES, THE FOLLOWING ITEMS WERE NOTICED TO BE WORN AND HAVE CRACKS SCRATCHES AND GOUGES: GII PS HI FLEX ISRT TR S3-4 9 ((B)(4)), GII PS HI FLEX ISRT TR S5-6 9 ((B)(4)) AND GII PS HI FLEX ISRT TR S5-6 11 ((B)(4)). NO CASE INVOLVED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914046 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT DURING FIELD INSPECTION THE GII PS HI FLEX ISRT TR S5-6 9 WAS CHIPPED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773251 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT GENESIS II PS HI FLEX INSERT TRIAL WAS CHIPPED, WITH PLASTIC LAYERS COMING OFF. THIS WAS NOTICED AFTER SURGERY; THEREFORE, THE PATIENT WAS NO LONGER INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401943 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT GENESIS II PS HI FLEX INSERT TRIAL WAS CHIPPED, WITH PLASTIC LAYERS COMING OFF. THIS WAS NOTICED AFTER SURGERY; THEREFORE, THE PATIENT WAS NO LONGER INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401876 ↗
• MalfunctionJan 26, 2021Crack; Crack

  IT WAS REPORTED THAT, AFTER A TKA, THE STERILE PROCESSING TECH NOTICED THAT THE GII PS HI FLEX ISRT TR S5-6 9 WAS CRACKED AND GOUGED. INCIDENT OCCURRED AFTER THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229996 ↗
• InjuryJan 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE GENESIS II PS HI FLEX INSERT TR S5-6 9 BROKE DURING IMPACTION, PIECES WERE RETRIEVED BY HAND. PROCEDURE WAS FINISHED WITH THE SAME DEVICE. THERE WAS NO DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11144598 ↗
• MalfunctionDec 16, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S5-6 9 IS PRESENTING WEAR AND TEAR. IT HAS CHIPS AND CRACKS. NO CASE RELATED. 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 11016811 ↗
• MalfunctionNov 3, 2020Crack; Crack

  IT WAS REPORTED THAT GENESIS II PS HI FLEX INSERT TR S5-6 9 HAS CRACKS. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10782798 ↗
• MalfunctionNov 2, 2020Crack; Crack

  IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S5-6 9 CANNOT BE STERILIZED DUE TO THE CRACKS THAT IT HAS. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10771658 ↗