GENESIS II 71430815Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010213402), received between Aug 20, 2020 and Apr 19, 2022 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionApr 19, 2022Crack; Crack

  IT WAS REPORTED THAT AFTER TKA, THE SALES REP DISCOVERED THE G2 P/S ART TR SZ3-4 9MM AND THE G2 P/S ART TR SZ3-4 11MM THE CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14149697 ↗
• MalfunctionJan 28, 2022Flaked; Flaked

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, A GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 3-4 9MM WAS NOTICED TO BE CHIPPED. SURGERY WAS PERFORMED, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN IF ANY DELAY OCCURRED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388673 ↗
• MalfunctionJul 22, 2021Crack; Crack

  IT WAS REPORTED THAT A G2 P/S ART TR SZ3-4 9 MM (B)(4) AND A G2 P/S ART TR SZ5-6 9 MM (G2 P/S ART TR SZ5-6 9 MM) HAD BEEN REPORTED AS HAVING CRACKS IN THEM. AS THIS WAS NOTICED UPON INSPECTION THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211690 ↗
• InjuryMay 31, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE GENESIS II P/S ART TR SIZE 3-4 9MM BROKE INSIDE THE PATIENT. THE SURGEON WAS USING A POLY INSERTER WITH A MALLET WHILE TRYING TO PUT IT IN. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909995 ↗
• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THAT THE GENESIS II P/S ART TR SIZE 3-4 9MM IS BROKEN AND DOES NOT HOLD UNIVERSAL SPACERS. AS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912629 ↗
• MalfunctionAug 20, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING OFFICE INSPECTION PROCESS, THE G2 P/S ART TR SZ3-4 9MM INSERT WAS FOUND CHIPPED AND/OR DAMAGED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10431200 ↗