GENESIS II 71430408Recalls & reported problems
Smith & Nephew, Inc. · GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 3-4 9MM · Class 1
All models of GENESIS II (462)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Genesis II posterior stabilized high flexion trial insert is a plastic trial component used to size knee implants during surgery. The 32 reports mostly describe the insert breaking, cracking, flaking or chipping during surgery or while sitting in storage, sometimes with pieces of plastic fragmenting. Two reports mention injuries and none describe a death. Most reports note the patient was not affected. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03596010493033), received between Feb 27, 2019 and Apr 1, 2025 — classified as 2 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Break” (13 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.
Reports received per month
Most reported problems
Device problems
- Break13
- Crack11
- Naturally Worn7
- Flaked5
- Material Fragmentation2
- Scratched Material2
- Defective Device1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Patient Involvement6
- No Consequences Or Impact To Patient5
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2025Break; Break
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) GII PS HI FLEX ISRT TR S3-4 9 BROKE WHEN THE SURGEON IMPACTED IT WHILE TESTING THE SIZE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO DELAYS OR INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21748812 ↗MalfunctionSep 13, 2022Material Fragmentation; Material Fragmentation; Naturally Worn
IT WAS REPORTED THAT AFTER SURGERY, ONE (1) GII PS HI FLEX ISRT TR S3-4 9 HAS BECOME WORN OUT OVER TIME AND THE PLASTIC IS CHIPPING IN SOME REGIONS ON THE UNDERSIDE OF THE TRIAL. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15415209 ↗MalfunctionJun 12, 2022Flaked; Flaked
IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S3-4 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 14672390 ↗MalfunctionJun 12, 2022Flaked; Flaked
IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S3-4 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 14672331 ↗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 NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14671851 ↗MalfunctionJun 11, 2022Flaked; Flaked
IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S3-4 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 14671746 ↗MalfunctionFeb 1, 2022Crack; Crack
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII PS HI FLEX ISRT TR S3-4 9 CRACKED WHILE PUTTING IT IN. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13415421 ↗MalfunctionDec 6, 2021Crack; Crack
IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S3-4 9 WAS CRACKED. 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 12940878 ↗MalfunctionNov 15, 2021Break; Break
IT WAS REPORTED THAT, A GII PS HI FLEX ISRT TR S3-4 9 IS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12814903 ↗MalfunctionSep 14, 2021Material Discolored; Flaked; Naturally Worn; Material Discolored; Flaked; Naturally Worn
IT WAS REPORTED THAT A GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 3-4 9MM 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 12468805 ↗MalfunctionAug 25, 2021Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT A GII PS HI FLEX ISRT TR S3-4 9 IS EXTREMELY WORN AND CHIPPED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12363869 ↗MalfunctionJun 24, 2021Crack; Crack
IT WAS REPORTED THAT, DURING A TKA, SEVEN (7) GENESIS II PS HI FLEX INSERT TRIALS ARE CHIPPED AND CRACKED INSIDE THE PATIENT. 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 12059651 ↗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 11967598 ↗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 11914011 ↗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 11401915 ↗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 11401796 ↗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 11401766 ↗InjuryFeb 15, 2021Break; Break
IT WAS REPORTED THAT, GENESIS II PS HIGH FLEX INSERT TRIAL DEVICE BROKE. THE DEVICE BROKE DURING SURGERY, WHILE INSIDE THE PATIENT. ALL PARTS WERE VERIFIED RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11326450 ↗MalfunctionJan 15, 2021Break; Naturally Worn
IT WAS REPORTED THAT, PS HIGH FLEX INSERT TRIAL DEVICE IS EXTREMELY WORN AND IT IS ALSO CHIPPING IN WASH. NO CASE INVOLVED; THEREFORE, 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 11176850 ↗MalfunctionDec 16, 2020Crack; Naturally Worn; Crack; Naturally Worn
IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S3-4 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 11016840 ↗InjuryDec 8, 2020Break; Break
IT WAS REPORTED THAT, A GENESIS II PS HI FLEX INSERT TR S3-4 9 TRIAL BROKE DURING TRIALING. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS INSIDE THE PATIENT. ALL PIECES WERE RETRIEVED DURING CASE BUT THE TRIAL WAS LOST IN THE WASH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY (0-30 MIN) USING A BACK-UP DEVICE. 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 10967410 ↗MalfunctionNov 13, 2020Crack; Crack
IT WAS REPORTED THAT THE GENESIS II PS HI FLEX INSERT TRIALS ARE WORN AND CRACKED. 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 10838830 ↗MalfunctionNov 13, 2020Crack; Crack
IT WAS REPORTED THAT THE GENESIS II PS HI FLEX INSERT TRIALS ARE WORN AND CRACKED. 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 10838775 ↗MalfunctionNov 13, 2020Crack; Crack
IT WAS REPORTED THAT THE GENESIS II PS HI FLEX INSERT TRIALS ARE WORN AND CRACKED. 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 10838753 ↗MalfunctionNov 13, 2020Crack; Crack
IT WAS REPORTED THAT THE GENESIS II PS HI FLEX INSERT TRIALS ARE WORN AND CRACKED. 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 10838689 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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