iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111SPEC02Recalls & reported problems
Conformis, Inc. · N/A · Class 2
All models of iTotal Cruciate Retaining (CR) Knee Replacement System (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M572TCR111SPEC021), received between May 11, 2017 and Mar 24, 2021 — classified as 11 injuries.
The most frequently reported specific device problem is “Failure to Align” (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
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Appropriate Device Problem Term/Code Not Available2
- Failure to Align1
Patient problems
- Unspecified Infection6
- Loss of Range of Motion2
- No Code Available2
- Pain1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS HAVING A LYSIS OF ADHESIONS PROCEDURE TO GET MORE RANGE OF MOTION. THE PATIENT WAS NOT COMPLIANT WITH THEIR PT AND SCARRED DOWN. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: Loss of Range of Motion
MAUDE report 11566233 ↗InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: Unspecified Infection
MAUDE report 9860448 ↗InjuryNov 15, 2019Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS A STIFF KNEE. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: Loss of Range of Motion
MAUDE report 9328725 ↗InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS HAVING PAIN. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: Pain
MAUDE report 8515685 ↗InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: Unspecified Infection
MAUDE report 8409215 ↗InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: Unspecified Infection
MAUDE report 8400935 ↗InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: Unspecified Infection
MAUDE report 8268026 ↗InjuryJan 8, 2019Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS STIFFNESS. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: No Code Available
MAUDE report 8226053 ↗InjuryAug 8, 2018Failure to Align
IT WAS REPORTED THAT THE PATIENT HAS A LIGAMENTOUS LAXITY. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: No Code Available
MAUDE report 7761566 ↗InjuryJul 3, 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 7657862 ↗InjuryMay 11, 2017Adverse 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 6559654 ↗
Other Knee Arthroplasty Implantation System devices
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111111102Conformis, Inc. · Knee Arthroplasty Implantation System390 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121SPEC02Conformis, Inc. · Knee Arthroplasty Implantation System11 reports
- TRUMATCH 42-0906Depuy (Ireland) · Knee arthroplasty implantation system5 reports
- iTotal® Identity Cruciate Retaining Knee Replacement System TCR301111301Conformis, Inc. · Knee Arthroplasty Implantation System3 reports
- iTotal® CR iPoly™ Insert Kit RCR010080003Conformis, Inc. · Knee Arthroplasty Implantation System1 report
- VISIONAIRE V0200128Smith & Nephew, Inc. · Knee arthroplasty implantation system1 report
- iTotal Identity CR RCR301111301Conformis, Inc. · Knee Arthroplasty Implantation System1 report
- ITOTAL IDENTITY IMPACTOR ADAPTER 1080-213Conformis, Inc. · Knee Arthroplasty Implantation System1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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