iTotal® Identity Cruciate Retaining Knee Replacement System TCR000D00101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M572TCR000D001011), received between Sep 24, 2020 and Oct 6, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2020Break

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS VERY TIGHT IN DEEP FLEXION INTRA-OPERATIVELY. THE SURGEON NOTED THAT THERE APPEARED TO NOT BE ENOUGH SLOPE CUT USING THE METAL CUTTING GUIDE. HE DECIDED TO RECUT THE TIBIA TO FORM MORE SLOPE WITH THE SAW BLADE. IT WAS ALSO REPORTED THAT THE TRIAL FEMORAL COMPONENT SNAPPED IN HALF DURING THE TRIALING PHASE. THE SURGEON UTILIZED THE FEMORAL IMPLANT WITH THE TRIALS TO SUCCESSFULLY COMPLETE THE SURGERY. THESE ISSUES RESULTED IN A 29 MINUTE DELAY IN THE PROCEDURE.

  Patient problems: Loss of Range of Motion

  MAUDE report 10638890 ↗
• InjurySep 24, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S TIBIA WAS FRACTURED DURING INSERTION OF THE KEEL PUNCH. THE SURGEON UTILIZED SCREWS TO ADDRESS THE FRACTURE AND HAD THE PATIENT PARTIAL WEIGHT-BEARING FOR SIX WEEKS. THE SURGEON NOTED THAT THE PATIENT "WENT ON TO HEAL NICELY AND OBTAIN FULL RANGE OF MOTION".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Limb Fracture

  MAUDE report 10583761 ↗