GENESIS II 71430401Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010493019), received between Nov 12, 2018 and Feb 26, 2026 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 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 26, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII PS HI FLEX ISRT TR S1-2 9 FRACTURED WHILE TRIALING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454609 ↗
• MalfunctionDec 29, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII PS HI FLEX ISRT TR S1-2 9 WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, IT IS UNKNOWN HOW. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418654 ↗
• MalfunctionJan 3, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA, (1) GII PS HI FLEX ISRT TR S1-2 9 BROKE WHILE IMPUTING TRIAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087348 ↗
• MalfunctionSep 2, 2022Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT A GII PS HI FLEX ISRT TR S1-2 9 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 15351024 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT A GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 1-2 9MM WAS FOUND TO HAVE A PIECE SHEARED OFF FROM THE UNDERSIDE ON AN EDGE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069939 ↗
• MalfunctionJun 18, 2022Flaked; Flaked

  IT WAS REPORTED THAT THE GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 1-2 9MM IS FLAKING AND CHIPPING. IT IS UNKNOWN WHEN THIS WAS NOTICED AND IF THERE WAS A PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14740070 ↗
• MalfunctionJun 17, 2022Flaked; Flaked

  IT WAS REPORTED THAT THE GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 1-2 9MM IS FLAKING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14727830 ↗
• MalfunctionJun 17, 2022Flaked; Flaked

  IT WAS REPORTED THAT THE GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 1-2 9MM IS FLAKING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14727761 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIALS SIZES (SIZE 1-2 9MM, SIZE 1-2 11MM, SIZE 3-4 9MM, SIZE 3-4 11MM, SIZE 5-6 9MM, SIZE 5-6 11MM, SIZE 7-8 9MM AND SIZE 7-8 11MM) ARE FLAKING AND CHIPPING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671834 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE GII PS HI FLEX ISRT TR S1-2 9 WAS BROKEN AND DID NOT SEAT IN TIBIA TRIAL. SURGERY WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW SURGERY WAS FINISHED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659292 ↗
• MalfunctionOct 8, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII PS HI FLEX ISRT TR S1-2 9 WAS CRACKED AND DID NOT SEAT IN TIBIA TRIAL. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598229 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED DURING A FIELD INSPECTION THAT A GII PS HI FLEX ISRT TR S1-2 9 IS CHIPPED AND WORN. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476934 ↗
• MalfunctionAug 12, 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 12314231 ↗
• MalfunctionJun 24, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A TKA, SEVEN (7) GENESIS II PS HI FLEX INSERT TRIALS ARE CHIPPED AND CRACKED. SURGERY WAS RESUMED, WITH A DELAY LESS THAN OR EQUAL TO 30 MIN, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059614 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A CONSIGNMENT INSPECTION THE DEVICE WAS FOUND WITH CORROSION/DISCOLORATION. THE DEVICE WILL BE RETURNED. THE INVESTIGATION FOUND THAT THERE WERE LITTLE PIECES BREAKING OFF IN CERTAIN AREAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642972 ↗
• InjuryJan 4, 2021Break; Break

  IT WAS REPORTED THAT DURING A GENESIS II TOTAL KNEE REPLACEMENT, WHILE REMOVING THE TRIAL FROM THE PATIENT, THE SURGICAL ASSISTANT NOTICED THAT A PIECE OF PURPLE PLASTIC WAS STILL IN THE PATIENT. THERE APPEARS TO BE TWO PIECES OF PLASTIC MISSING, BUT ONLY ONE PIECE WAS RECOVERED FROM THE PATIENT. IT IS UNCERTAIN AS TO WHETHER THE POLY WAS ALREADY DAMAGED PRIOR TO USE OR IF BOTH PIECES SNAPPED OFF DURING THIS PARTICULAR CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11108720 ↗
• InjuryJan 4, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA WHILE REMOVING THE GENESIS II PS HI FLEX INSERT TR S1-2 9 FROM THE PATIENT, THE SURGICAL ASSISTANT NOTICED THAT A PIECE OF PURPLE PLASTIC WAS STILL IN THE PATIENT. THE SURGEON WASHED OUT THE PATIENT USING THE PULSE LAVAGE. THERE APPEARS TO BE TWO PIECES OF PLASTIC MISSING, BUT ONLY ONE PIECE WAS RECOVERED FROM THE PATIENT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. 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 11108335 ↗
• MalfunctionSep 15, 2020Break; Flaked; Mechanical Problem; Break; Flaked; Mechanical Problem

  IT WAS REPORTED THAT IN THE STERILIZATION PROCESS DEPARTMENT WAS NOTED A SMALL PIECE OF PLASTIC SPACER INSERT CHIPPED OFF. AS A RESULT, THE LOCKING MECHANISM OF THE TRIAL INSERT HAS BEEN DAMAGED AND CAN NO LONGER BE USED. THERE ARE NOT ANY PATIENT INVOLVED IN THE CASE. THE PROCEDURE PERFORMED BEFORE THE STERILIZATION PROCESS WAS COMPLETED WITHOUT DELAY AND WITH A BACKUP FROM SMITH NEPHEW. 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 10538197 ↗
• MalfunctionFeb 11, 2020Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE TRIAL INSERT CRACKED IN HALF WHILE INSERTING. NO INJURIES OR DELAYS REPORTED. A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9697069 ↗
• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED THAT DURING TKA A PIECE OF THE INSERT BROKE OFF INSIDE THE PATIENT WHEN PLACED ON THE TIBIAL TRAY TRIAL. ALL PIECES ACCOUNTED FOR. NO DELAY OR INJURY REPORTED. BACK UP WAS NOT REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8062446 ↗