GENESIS II 71430236Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010211910), received between Aug 21, 2020 and Oct 15, 2022 — classified as 1 injury, 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE POSTERIOR PORTION ON A GENESIS II ARTICULAR INSERT SPACER TRIAL SIZE 5-6 15MM CHIPPED AND WORN AWAY. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612576 ↗
• MalfunctionJun 5, 2022Break; Break

  IT WAS REPORTED THAT DURING INSPECTION, G2 INS SPAC TR SZ5-6 15MM WAS FOUND TO HAVE A HOLE WHERE A PIECE BROKE OFF. BACKUP DEVICE AVAILABLE AND NO DELAY OCCURRED DUE TO THIS EVENT SINCE THE EVENT WAS NOTICED DURING INSPECTION NO PATIENT WAS INVOLVED AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599744 ↗
• MalfunctionFeb 8, 2022Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT, A G2 INS SPAC TR SZ5-6 15MM WAS FOUND CRACKED IN HALF AFTER NORMAL WEAR AND TEAR USE. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478680 ↗
• 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 11967548 ↗
• InjuryNov 10, 2020Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, A PIECE OF PLASTIC FROM THE INSERT SPACER 5-6 15 MM BROKE OFF WHILE TRIALING THE KNEE. ALL PIECES RECOVERED. A SURGICAL DELAY NO LONGER THAN 30 MIN WAS REPORTED AND A SMITH AND NEPHEW BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10814882 ↗
• MalfunctionOct 16, 2020Break; Break

  IT WAS REPORTED THAT THE GENESIS II INS SPACER TRIAL SIZE 5-6 15MM IS CHIPPED. FAULT IN DEVICE WAS NOTICED DURING SET UP OR INSPECTION. PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO ANY PATIENT WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10693383 ↗
• MalfunctionAug 21, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE G2 INS SPAC TRIAL SZ5-6 15MM 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 10440384 ↗