GENESIS II 71421534Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010520333), received between May 5, 2021 and May 5, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2021Fracture; Pitted; Naturally Worn; Fracture; Pitted; Naturally Worn

  IT WAS REPORTED THAT DURING A TKA REVISION SURGERY THE GENESIS II CR DEEP FLEX INSERT S1-2 15M WAS PITTED AND WORN, THE KNEE CAPSULE HAD POLY DEBRIS IN IT WHEN OPENED. THE IMPLANT WAS EXTRACTED AND REPLACED WITH A DISHED CR INSERT; THEREFORE, THE PROCEDURE HAD TO BE FINISHED CHANGING THE SURGICAL TECHNIQUE. FURTHERMORE, THE PATIENT WAS NOT INJURED BEYOND THE DESCRIBED EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Bone Shedding Debris; Failure of Implant

  MAUDE report 11777471 ↗