iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121SPEC02Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M572TCR121SPEC021), received between May 31, 2017 and Oct 27, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2021Appropriate 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) 2018. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 12708206 ↗
• InjuryOct 1, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS AN INFECTION. PRIMARY SURGERY OCCURRED ON 04/16/2018. REVISION SURGERY PLANNED DATE IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12565229 ↗
• InjuryAug 20, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REPLACEMENT PARTS ARE ORDERED FOR REVISION SURGERY. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. THE ORIGINAL SURGERY DATE: (B)(6) 2017; REVISION SURGERY DATE: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12351187 ↗
• InjuryMar 10, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS. REASON FOR REVISION IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457465 ↗
• InjuryApr 30, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT HAS LOOSENING OF THE TIBIAL TRAY. THE SURGEON PLANS TO REVISE TO AN OFF-THE-SHELF SYSTEM.

  Patient problems: Failure of Implant

  MAUDE report 8566469 ↗
• InjuryMay 9, 2018Fracture

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED THEIR KNEE AND AS A RESULT DEVELOPED POSSIBLE INFECTION. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 7498142 ↗
• InjuryMay 2, 2018Unstable

  IT WAS REPORTED THAT THE PATIENT HAS INSTABILITY. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.

  Patient problems: Complaint, Ill-Defined; No Code Available

  MAUDE report 7479179 ↗
• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.

  Patient problems: Unspecified Infection

  MAUDE report 7422308 ↗
• InjuryDec 27, 2017Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. IT WAS ALSO REPORTED THAT THE PATIENT HAS TIBIAL IMPLANT LOOSENING. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS AND THE TIBIAL TRAY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7147370 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.

  Patient problems: Unspecified Infection

  MAUDE report 7133233 ↗
• InjuryMay 31, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT A PROCEDURE IS PLANNED TO PERFORM SOFT TISSUE RELEASES TO LOOSEN THE KNEE AND TO EXCHANGE THE POLY INSERTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6600462 ↗