GENESIS II 71430228Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010211873), received between Aug 17, 2020 and Mar 7, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT, DURING A PRIMARY KNEE REPLACEMENT SURGERY, ONE (1) G2 INS SPAC TR SZ5-6 13MM BROKE. THE SURGEON TRIED TO PUT IT IN BUT HE MADE LOT OF FORCE. NO PIECES FELL INTO THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541659 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) G2 INS SPAC TR SZ5-6 13MM WAS BROKEN. THE PROCEDURE WAS PERFORMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024113 ↗
• MalfunctionMay 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) G2 INS SPAC TR SZ5-6 13MM FRACTURED WHEN FITTING. NO PIECES FALL INSIDE THE PATIENT 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 19240058 ↗
• MalfunctionOct 18, 2022Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT ONE REPORT SOURCE: INS SPAC TR SZ5-6 13MM IS WORN FROM USAGE. DURING INVESTIGATION THE TRIAL WAS FOUND BROKEN. AS THIS WAS NOTICED DURING SET UP OR INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626607 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE FRONT OF THE GENESIS II ARTICULAR INSERT SPACER TRIAL SIZE 5-6 13MM BROKE OFF, OCCURRING UNDER NORMAL WEAR AND TEAR. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. AS IT OCCURRED AFTER PROCEDURE PATIENT WAS NOT LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14711011 ↗
• MalfunctionFeb 28, 2022Crack; Crack

  IT WAS REPORTED THAT A G2 INS SPAC TR SZ5-6 13MM IS CRACKED AND WILL NO LONGER SNAP INTO THE TRIAL INSERT. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625385 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT, A G2 INS SPAC TR SZ5-6 13MM WAS BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546074 ↗
• MalfunctionJul 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A G2 INS SPAC TR SZ5-6 13MM HAD BROKEN OFF DURING PROCESSING, IT WILL NO LONGER LOCK ON. THIS HAPPENED AFTER USE IN PATIENT. · SURGERY HAD BEEN COMPLETED, 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 12114799 ↗
• MalfunctionFeb 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION IT WAS NOTICED THAT THE GENESIS II INS SPAC TR SIZE 5-6 13MM WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326139 ↗
• MalfunctionNov 23, 2020Break; Break

  IT WAS REPORTED THAT, DURING SET UP BEFORE CASE, THE GENESIS II ARTICULAR INSERT SPACER TRIAL SIZE 5-6 13MM BROKE IN HALF. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886775 ↗
• MalfunctionAug 17, 2020Break; Break

  IT WAS REPORTED THAT DURING AN OFFICE INSPECTION IT WAS FOUND THESE INSERT TRIALS VERY WORN AND CHIPPED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10414346 ↗