GENESIS II 71430422Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010494474), received between May 2, 2019 and May 28, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE CONNECTION TAB OF ONE (1) GII SPC {} P/S CAM MODULE SZ 8 BROKE DURING INSERTION INTO FEMORAL TRIAL. THE BROKEN PIECE WAS LOCATED AND REMOVED FROM OPERATIVE SITE. 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 17016089 ↗
• MalfunctionOct 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT A GII PS HI FLEX ISRT TR S7-8 9 IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15593358 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII PS HI FLEX ISRT TR S7-8 9 BROKE. THIS OCCURRED WHILE THE DEVICE WAS HANDLED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124400 ↗
• MalfunctionJun 13, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S7-8 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 14678277 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S7-8 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 14672381 ↗
• MalfunctionJun 12, 2022Flaked; Flaked

  IT WAS REPORTED THAT GII PS HI FLEX ISRT TR S7-8 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 14672326 ↗
• MalfunctionSep 14, 2021Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT A GII PS HI FLEX ISRT TR S7-8 9 IS CHIPPED AND WORN OUT. AS THIS WAS NOTICED UPON WAREHOUSE INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470995 ↗
• 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 9MM, ONE (1) ECHELON 260MM POROUS BOWED FEMORAL COMPONENT STANDARD COLLAR SIZE 16 LEFT, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 7-8 9MM, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 7-8 11MM, ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 5-6 9MM AND ONE (1) GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT TRIAL SIZE 3-4 11MM 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 12314239 ↗
• MalfunctionMar 12, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA THE GII PS HI FLEX ISRT TR S7-8 9 BROKE DURING WASH PROCESS. INCIDENT OCCURRED AFTER THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478162 ↗
• MalfunctionFeb 28, 2021Break; Break

  IT WAS REPORTED THAT AFTER A PROCEDURE, THE GENESIS II INSERT TRIAL WAS NOTICED TO BE CHIPPED AND SCRATCHED. THIS WAS NOTICED AFTER SURGERY; THEREFORE, THE PATIENT WAS NO LONGER INVOLVED AT THAT MOMENT. 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 11391030 ↗
• MalfunctionDec 4, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TRIAL BROKE IN HALF. NO BACK-UP DEVICE WAS AVAILABLE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410759 ↗
• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, PART OF THE PLASTIC ON THE TRIAL CHIPPED OFF DURING SURGERY. ALL PIECES WERE RECOVERED FROM THE PATIENT AND AN X-RAY WAS DONE TO CONFIRM. NO DELAY REPORTED. PROCEDURE FINISHED WITH THE SAME DEVICE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573970 ↗