GENESIS II 71430502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010212146), received between Jul 23, 2020 and Mar 15, 2022 — classified as 1 injury, 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2022Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING TKA, THE G2 C/R ART TR SZ5-6 11MM WAS DIFFICULT TO PLACE AND A SECTION FRACTURED INSIDE THE PATIENT. ALL PIECES WERE RECOVERED WITH TWEEZERS, BUT STERILE SERVICES DISPOSED OF THE PIECES DUE TO THE SHARP EDGES. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED. FURTHER PATIENT INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13774953 ↗
• MalfunctionNov 20, 2020Break; Break

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE DEVICE HAS CRACKS IN IT. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED. 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 10880490 ↗
• MalfunctionJul 23, 2020Break; Break

  IT WAS REPORTED THAT THE POLY IS CHIPPED AND WORN. FAULT IN DEVICE WAS NOTICED DURING SET UP OR INSPECTION. PROCEDURE WAS PERFORMED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO DELAY 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 10312221 ↗