GENESIS II 71433447Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556480175), received between Jun 22, 2021 and Apr 25, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE SURGEON SMILED THE GII CR DEEP FLX ISR TR S7-8 10 DEVICE WITH A MALLET. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY CHANGING THE SURGICAL PROCEDURE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. THE INVESTIGATION RESULTS INDICATE THE DEVICE WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811770 ↗
• MalfunctionFeb 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, UPON IMPACTION INTO THE TIBIAL TRIAL, ONE (1) GII CR DEEP FLX ISR TR S7-8 10 BROKE IN HALF. 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 16278098 ↗
• MalfunctionJun 22, 2021Crack; Material Deformation; Naturally Worn; Scratched Material; Crack; Material Deformation; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT, ONE (1) G2 DISH ART TR SZ7-8 11MM, ONE (1) G2 INS SPAC TR SZ7-8 13MM, FOUR (4) GII CR DEEP FLX ISR TR S3-4 10, THREE (3) GII CR DEEP FLX ISR TR S5-6 10, TWO (2) GII CR DEEP FLX ISR TR S7-8 10 AND TWO (2) GII CR DEEP FLX ISR TR S7-8 12 ARE OLD AND SCUFFED UP. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12045869 ↗
• MalfunctionJun 22, 2021Crack; Material Deformation; Naturally Worn; Scratched Material; Crack; Material Deformation; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT, ONE (1) G2 DISH ART TR SZ7-8 11MM, ONE (1) G2 INS SPAC TR SZ7-8 13MM, FOUR (4) GII CR DEEP FLX ISR TR S3-4 10, THREE (3) GII CR DEEP FLX ISR TR S5-6 10, TWO (2) GII CR DEEP FLX ISR TR S7-8 10 AND TWO (2) GII CR DEEP FLX ISR TR S7-8 12 ARE OLD AND SCUFFED UP. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12045853 ↗
• MalfunctionJun 22, 2021Crack; Material Deformation; Naturally Worn; Scratched Material; Crack; Material Deformation; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT, ONE (1) G2 DISH ART TR SZ7-8 11MM, ONE (1) G2 INS SPAC TR SZ7-8 13MM, FOUR (4) GII CR DEEP FLX ISR TR S3-4 10, THREE (3) GII CR DEEP FLX ISR TR S5-6 10, TWO (2) GII CR DEEP FLX ISR TR S7-8 10 AND TWO (2) GII CR DEEP FLX ISR TR S7-8 12 ARE OLD AND SCUFFED UP. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12045163 ↗