GENESIS II 71430574Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010212214), received between Apr 11, 2021 and Nov 23, 2021 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861545 ↗
• MalfunctionApr 11, 2021Break; Break

  ((B)(4)) IT WAS REPORTED THAT DURING TKA SURGERY, THE GENESIS II RESURFACING PATELLA TRIAL 26MM BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT. ((B)(4)) IT WAS REPORTED THAT DURING TKA SURGERY, THE GENESIS II RESURFACING PATELLA TRIAL 29MM BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT. ((B)(4)) IT WAS REPORTED THAT DURING TKA SURGERY, THE GENESIS II RESURFACING PATELLA TRIAL 32MM BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646712 ↗