GENESIS II 71430829Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010213495), received between Apr 24, 2019 and Apr 5, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2026Break

  IT WAS REPORTED THAT, DURING A TKA, THE PART OF A G2 P/S ART TR SZ5-6 9MM WHERE IT IS LEVERED OUT OF THE KNEE AFTER TRIALING BROKE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786985 ↗
• MalfunctionMar 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, A SMALL FRAGMENT OF ONE (1) G2 P/S ART TR SZ5-6 9MM BROKE OFF DURING THE IMPACT PROCESS. THE BROKEN PIECE AND DAMAGED TRIAL WERE IMMEDIATELY REMOVED WITH TWEEZERS. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A THICKER-SIZED TRIAL AS A BACK-UP DEVICE FROM S+N. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694984 ↗
• MalfunctionOct 5, 2022Break; Break

  IT WAS REPORTED THAT THE ANTERIOR ASPECTS OF A G2 P/S ART TR SZ5-6 9MM INSERT WAS BROKEN. AS THIS WAS NOTICE DURING SET UP OR INSPECTION THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544452 ↗
• MalfunctionJul 30, 2022Fracture; Scratched Material; Fracture; Scratched Material

  IT WAS REPORTED THAT, A G2 P/S ART TR SZ5-6 9MM WAS SCRATCHED AND CHIPPED. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136784 ↗
• MalfunctionJun 10, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 5-6 9MM CHIPPED INSIDE THE PATIENT DURING INSERTION. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655114 ↗
• MalfunctionMar 29, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING KNEE REVISION SURGERY OF A PRIMARY TRIATHLON TKR TO A LEGION REVISION TKR, A GENESIS II ARTICULAR INSERT SPACER TRIAL SIZE 5-6 13MM WAS NOT FIRMLY ATTACHING TO THE GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 5-6 9MM. ON CLOSER INSPECTION, IT WAS OBSERVED THAT THE GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 5-6 9MM SEEMED TO HAVE CRACKS IN THE WHITE ¿O RINGS¿ THAT ARE INSET INTO THE HOLES THAT THE GENESIS II ARTICULAR INSERT SPACER TRIAL SIZE 5-6 13MM CLICKS INTO. THE INSERT SPACER DOES NOT APPEAR TO HAVE ANY DAMAGE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP CONSTRAINED INSERT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935404 ↗
• MalfunctionDec 14, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A GENESIS II P/S ARTICULAR TRIAL SIZE 5-6 9MM CRACKED WHEN REMOVING AFTER TRIALING WITH IT. THIS HAPPENED OUTSIDE THE PATIENT. 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 13005244 ↗
• 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 12211675 ↗
• 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 11968094 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT THE 5-6 9MM POLY TRIAL BROKE DURING A CASE. THE DEVICE BROKE OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. PATIENT WAS NOT INJURED AND THERE WAS NO DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320882 ↗
• MalfunctionDec 16, 2020Crack; Crack

  IT WAS REPORTED THAT THE G2 P/S ART TR SZ5-6 9MM IS PRESENTING WEAR AND TEAR. IT HAS CHIPS AND CRACKS. NO CASE RELATED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11017199 ↗
• MalfunctionAug 21, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE G2 P/S ART TRIAL SZ5-6 9MM 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 10440387 ↗
• MalfunctionApr 24, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE TIBIAL TRIAL BROKE. NO DELAY OR INJURY REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547074 ↗