GENESIS II 71430226Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010211866), received between Apr 1, 2020 and Jun 4, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT, DURING TKA SURGERY A PIECE OF THE G2 INS SPAC TR SZ3-4 13MM BROKE OFF AS A RESULT OF USING A SURGICAL INSTRUMENT TO DISLODGE IT FROM THE 9 MM TRIAL. THE PROCEDURE WAS COMPLETED, 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 19459872 ↗
• MalfunctionJun 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA, THE G2 INS SPAC TR SZ3-4 13MM BROKE IN HALF OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739800 ↗
• MalfunctionJun 9, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT 4 CONSTRAINED INSERT TRIALS, 4 ARTICULAR INSERT SPACER TRIALS, 4 POSTERIOR STABILIZED HIGH FLEXION INSET TRIALS AND 3 POSTERIOR STABILIZING ARTICULAR TRIALS FROM GENESIS II SYSTEM ARE BEING RETURNED FOR REPLACEMENT BECAUSE THEY'RE COVERED IN SCRATCHES, CHIPS AND CRACKS. NO CASE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967519 ↗
• MalfunctionAug 21, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE G2 INS SPAC TR SZ3-4 13MM IS VERY WORN, CHIPPED, AND/OR CRACKED. AS THIS WAS NOTICED UPON OFFICE INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10440386 ↗
• MalfunctionAug 20, 2020Break; Break

  IT WAS REPORTED THAT, DURING OFFICE INSPECTION PROCESS, THE G2 INS SPAC TR SZ3-4 13 MM INSERT WAS FOUND CHIPPED AND/OR DAMAGED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10431186 ↗
• MalfunctionApr 1, 2020Break; Break

  IT WAS REPORTED THAT DURING A TKA, WHILE THE DOCTOR WAS REMOVING TRIAL POLY, A PIECE OF THE GENESIS II INS SPAC TR SIZE 3-4 13MM BROKE OFF. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9912483 ↗