iTotal Identity Posterior Stabilized Knee Replacement System TPS301111301Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M572TPS3011113011), received between Mar 22, 2022 and Mar 22, 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.

• InjuryMar 22, 2022Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT IN THE RECEIVED KIT, THE TRIAL TIBIAL BASE PLATE WAS PS BUT THE REAL TIBIAL BASE PLATE IMPLANTED WAS A CR. ALL POLY INSERTS WERE PS. THE PATIENT HAD TO UNDERGO REVISION SURGERY TO CORRECT THIS. ORIGINAL SURGERY WAS ON (B)(6) 2022. REVISION SURGERY WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 13850953 ↗