GENESIS II 71430416Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010493064), received between Sep 4, 2020 and Feb 4, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Crack” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA , WHILE IN RANGE OF MOTION ONE (1) GII PS HI FLEX ISRT TR S5-6 11 BROKE. ALL PIECES RECOVERED. 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 16301744 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, A GII PS HI FLEX ISRT TR S5-6 11 WAS BROKEN. NO PATIENT WAS INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393780 ↗
• MalfunctionSep 2, 2022Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT A GII PS HI FLEX ISRT TR S5-6 11 IS NOT SUITABLE FOR USE AS THE PLASTIC HAS CHIPPED OFF. AS THIS WAS NOTED IN A NON-SURGICAL SETTING, THERE WERE NO PATIENTS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351044 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S5-6 11 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 14672412 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S5-6 11 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 14672380 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S5-6 11 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 14671768 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S5-6 11 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 14671570 ↗
• MalfunctionMay 22, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, IT WAS NOTICED THAT THE PLASTIC OF A GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 5-6 11MM HAD CHIPPED OFF THE BOTTOM. TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. AS THIS HAPPENED AFTER SURGERY THERE WAS NOT PATIENT INVOLVEMENT OR AFFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467126 ↗
• MalfunctionMay 6, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA PROCEDURE, THE GII PS HI FLEX ISRT TR S5-6 11 WAS CRACKED. AS THIS WAS NOTICED BEFORE PROCEDURE, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307593 ↗
• MalfunctionFeb 9, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING INSPECTION, A GII PS HI FLEX ISRT TR S5-6 11 WAS FOUND WITH CRACKS, MAKING THEM UNFIT FOR FURTHER USE IN SURGERY. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13499965 ↗
• MalfunctionDec 3, 2021Crack; Crack

  IT WAS REPORTED THAT THESE INSERT TRIALS AND SPACERS ARE CRACKED: GII PS HI FLEX ISRT TR S5-6 11, UNIV ISRT SPACER SZ5-6 13M, UNIV ISRT SPACER SZ 5-6 15MM, GII CR DEEP FLX ISR TR S5-6 9, AND GII CR DEEP FLX ISR TR S5-6 11. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924867 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT A GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 5-6 11MM IS CHIPPED AND WORN OUT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476705 ↗
• MalfunctionAug 11, 2021Crack; Crack

  IT WAS REPORTED THAT A GII PS HI FLEX ISRT TR S5-6 11 HAS A LARGE CRACK DOWN THE MIDDLE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307647 ↗
• MalfunctionJul 7, 2021Flaked; Naturally Worn; Flaked; Naturally Worn

  IT WAS REPORTED THAT, DURING A TKA, A GENESIS II PS HI FLEX INSERT TR S5-6 11 WAS CHIPPED AND WORN. THIS WAS NOTICED WHILE SETTING UP, BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132244 ↗
• 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 11914083 ↗
• 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 11401797 ↗
• 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 11 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 11229994 ↗
• MalfunctionJan 14, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING SERVICE/PM IT WAS NOTICED THAT THE GII PS HI FLEX ISRT TR S5-6 11 HAD TWO CRACKS GOING UP THE SIDE AND IT COULD NOT BE CLEANED. NO CASE REPORTED; THEREFORE, 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 11174581 ↗
• MalfunctionDec 29, 2020Crack; Crack

  IT WAS REPORTED THAT AFTER PROCEDURE, THEY FOUND THE TRIAL POLY CRACKED. NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS STAGE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088010 ↗
• MalfunctionSep 4, 2020Break; Break

  IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S5-6 11 WAS FOUND TO BE GOUGED AND CRACKED DURING A ROUTINE EFIP INSPECTION. THERE WERE NO REPORTED PROBLEMS FROM ANY CASES.

  Patient problems: No Patient Involvement

  MAUDE report 10497608 ↗