GENESIS II 71430444Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010512536), received between May 28, 2020 and Mar 31, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING TKA SURGERY, A GII CR DEEP FLX ISR TR S3-4 9 WAS CHIPPED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658683 ↗
• MalfunctionMar 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY THE GII CR DEEP FLX ISR TR S3-4 9 BROKE OFF. THE PLASTIC SNAPPED IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY; HOWEVER IT IS UNKNOWN HOW. THE PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527359 ↗
• MalfunctionJun 18, 2022Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, A GII CR DEEP FLX ISR TR S3-4 9 IS CHIPPED AND BURRED. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14740074 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A GII CR DEEP FLX ISR TR S3-4 9 INSERT TRIAL CRACKED. NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, CHANGE IN SURGICAL TECHNIQUE. NO DELAY REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629601 ↗
• MalfunctionDec 6, 2021Crack; Crack

  IT WAS REPORTED THAT THE GII CR DEEP FLX ISR 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 12941175 ↗
• MalfunctionMay 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRANSIT OF A GII CR DEEP FLX ISR TR S3-4 9 WAS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863174 ↗
• MalfunctionApr 5, 2021Crack; Crack

  IT WAS REPORTED THAT A GENESIS II CR DEEP FLX ISR TR S3-4 9 WAS CRACKED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612180 ↗
• MalfunctionMar 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION IT WAS NOTICED THAT THE LEGION INSPECTION TRIALS AND IMPACTOR ARE BUSTED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586416 ↗
• MalfunctionAug 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY THE TRIAL SNAPPED IN HALF, NOTHING FELL INTO PATIENT AND ALL PIECES RECOVERED. NO HARM TO PATIENT, NO DELAY TO PROCEDURE. THE SURGERY WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10408791 ↗
• MalfunctionMay 28, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT THE TRIAL HAS BEGUN TO CHIP AND A SMALL PIECE HAS BROKEN OFF. NO CASE INVOLVED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10097413 ↗