iTotal® Identity Cruciate Retaining Knee Replacement System TCR301111301Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M572TCR3011113011), received between Nov 2, 2020 and Nov 26, 2025 — classified as 2 injuries, 1 malfunction.

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

• InjuryNov 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT IS HAVING REVISION PROCEDURE TO ADDRESS TIBIAL COMPONENT LOOSENING FROM (B)(6) 2025 TOTAL KNEE REPLACEMENT.

  Patient problems: Aseptic loosening

  MAUDE report 23657871 ↗
• MalfunctionApr 14, 2021Material Erosion; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT HAD TIBIAL EROSION WITHIN THE LATERAL COMPARTMENT OF THEIR TIBIA DISCOVERED DURING THE PLANNING FOR THEIR ITOTAL KNEE REPLACEMENT. CONFORMIS ENGINEERING AND THE SURGEON REVIEWED THE CASE AND DEEMED THAT THE PATIENT WOULD NOT BE A CANDIDATE FOR AN ITOTAL IMPLANT. THE SALES AGENT CONTACTED CUSTOMER SERVICE VIA PHONE TO CANCEL THE CASE, BUT DID NOT SUBMIT THE CANCELLATION IN WRITTEN FORM AS WAS REQUESTED BY CUSTOMER SERVICE. WITHOUT THE CANCELLATION INITIATED, THE CASE CONTINUED THROUGH PRODUCTION AND WAS SENT TO THE HOSPITAL FOR THE PROCEDURE. THE SURGEON PROCEEDED WITH THE CASE AND FOUND THAT THE TIBIAL BASE PLATE COULD NOT PROVIDE ADEQUATE COVERAGE WITHIN THE LATERAL PORTION OF THE TIBIA AND WAS UNSTABLE IN FLEXION. A STRYKER TIBIAL BASE PLATE WAS UTILIZED ALONG WITH THE CONFORMIS FEMORAL COMPONENT AND CONFORMIS CUTTING GUIDES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Erosion

  MAUDE report 11668123 ↗
• InjuryNov 2, 2020Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WILL RECEIVE AN IRRIGATION AND DRAINAGE AS WELL AS A POLY INSERT EXCHANGE. REASON FOR THE PROCEDURE IS UNKNOWN. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.

  Patient problems: Insufficient Information

  MAUDE report 10775058 ↗