GENESIS II 71430402Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010493026), received between May 14, 2019 and Jun 12, 2022 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT THE GII PS HI FLEX ISRT TR S1-2 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 14672385 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S1-2 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 14672330 ↗
• 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 14671845 ↗
• MalfunctionJun 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S1-2 11 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 14671741 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT A GENESIS II PS HIGH FLEXION INSERT TRIAL SZ 1-2 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 12476412 ↗
• 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 12059630 ↗
• MalfunctionFeb 5, 2021Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING CONSIGNMENT INSPECTION THE DEVICE WAS FOUND WITH BURRS AND NICKS. DEVICE WILL BE RETURNED. AFTER INVESTIGATION, UPON PRODUCT'S RECEIPT, IT HAS BEEN CONFIRMED THAT THE DEVICE IS CRACKED/BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11285084 ↗
• InjuryAug 25, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE GII PS HI FLEX ISRT TR S1-2 11 BROKE WHILE BEING USE INSIDE THE PATIENT. SURGEON WAS USING IT WHILE TRIALING FOR SIZE BETWEEN SIZE 9MM AND 11MM. IT BROKE IN HALF. ALL PIECES RECOVERED. PATIENT WAS NOT HURT NOR DID IT CHANGE THE OUTCOME OF THE CASE IN ANY WAY. S&N BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10452254 ↗
• MalfunctionAug 25, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S1-2 11 HAS DEVELOPED A CHIP ON THE GUIDE IN THE BOTTOM. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10449583 ↗
• MalfunctionMar 2, 2020Break; Break

  IT WAS REPORTED THAT THE PS TRIAL BROKE WHILE TRAILING. THIS WAS DISCOVERED DURING A TKA. IT IS UNKNOWN IF A DELAY WAS ASSOCIATED TO THE FAILURE. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9776417 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, SOME PLASTIC BROKE OFF WHILE TAKING THE TRIAL OUT OF THE PATIENT. ALL PIECES OF PLASTIC WERE REMOVED FROM THE PATIENT. NO HARM TO PATIENT OR STAFF. NO DELAY TO PROCEDURE. SMITH & NEPHEW BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8610492 ↗