iTotal Identity CR TCR-101-111211Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M572TCR1011112111), received between Aug 18, 2022 and Dec 22, 2022 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2022. THE REVISION SURGERY IS PLANNED FOR (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 16034979 ↗
• InjurySep 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS RECURRENT HEMARTHROSIS, AND CHRONIC PAIN WITH MECHANICAL SYMPTOMS LIKE STIFFNESS. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15480794 ↗
• InjurySep 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.

  Patient problems: Joint Laxity

  MAUDE report 15374846 ↗
• InjurySep 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.

  Patient problems: Joint Laxity

  MAUDE report 15374793 ↗
• InjurySep 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.

  Patient problems: Joint Laxity

  MAUDE report 15374764 ↗
• InjurySep 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15352351 ↗
• InjurySep 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT'S HUSBAND CALLED IN STATED THE PATIENT HAS HAD TWO CONFORMIS KNEE IMPLANTS, IT'S BEEN THREE YEARS SINCE THE FIRST KNEE IMPLANT WITH NO ISSUES. THIS SECOND KNEE HAS NOW BECOME INFECTED. HE STATED THE HOSPITAL HAS TALKED ABOUT CLEANING IT OUT. DR. SILVER IS IN THE CARIBBEAN AND HE CANNOT CONTACT HIM. HE STATED THE KNEE INFECTION HAS WENT TO HIS WIFE'S BACK AND SHE IS GOING TO HAVE TO HAVE SURGERY ON IT AND THEY KEEP GETTING CONFLICTING INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 15341247 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15254379 ↗