GENESIS II 71422088Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010496447), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 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.

• InjuryJul 28, 2022Improper or Incorrect Procedure or Method; Loosening of Implant Not Related to Bone-Ingrowth; Improper or Incorrect Procedure or Method; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER AN INITIAL LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2012 DUE TO SEVERE POST-TRAUMATIC ARTHRITIS, THE PATIENT EXPERIENCED THE TIBIAL PROSTHESIS LOOSENING, SYNOVITIS AND OSTEOLYTIC EROSION UNDER THE MEDIAL TIBIAL PLATEAU. THE PATIENT UNDERWENT A LEFT REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, ONLY THE PATELLA COMPONENT WAS RETAINED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15123037 ↗