GENESIS II 71430234Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010211903), received between Sep 28, 2020 and Apr 20, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) G2 INS SPAC TR SZ3-4 15MM BROKE WHILE IMPACTED. A BROKEN PIECE WAS REMOVED FROM FIELD. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 21870332 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA A G2 INS SPAC TR SZ3-4 15MM BROKE WHILE TRIALING. NO PIECES FELL INSIDE THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314857 ↗
• 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 11967545 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A CONSIGNMENT INSPECTION THE DEVICE WAS FOUND WITH CORROSION/DISCOLORATION. THE DEVICE WILL BE RETURNED. THE INVESTIGATION FOUND THAT THERE WERE LITTLE PIECES BREAKING OFF IN CERTAIN AREAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642515 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT THE SPACER BROKE IN HALF. NO CASE WAS INVOLVED. 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 11016079 ↗
• MalfunctionDec 14, 2020Flaked; Flaked

  IT WAS REPORTED THAT, THE SURFACE OF A GEN II INSERT TRIAL 3-4 15MM WAS DELAMINATING. INCIDENT OCCURRED IN THE STERILIZATION DEPARTMENT. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11003580 ↗
• MalfunctionSep 28, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE G2 INS SPAC TR SZ3-4 15MM BROKE. THIS HAPPENED DURING USE OUTSIDE THE PATIENT. NO DELAY. PROCEDURE CONCLUDED WITH THE SAME DEVICE. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10597454 ↗