iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111111102Recalls & reported problems

All models of iTotal Cruciate Retaining (CR) Knee Replacement System (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Conformis iTotal CR knee replacement has 390 reports in the FDA database, 371 of them describing injuries and no deaths. Many reports describe patients needing another surgery because of looseness, instability, sinking of the tibia, or limited range of motion. Reports also mention infection. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 390
Deaths reported: 0
Injuries reported: 371
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 390 adverse event reports that list this exact device (DI M572TCR1111111021), received between Mar 24, 2016 and Apr 30, 2025 — classified as 371 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (72 reports).

7 other recalls cover devices cleared under the same FDA submission (K140423, K142161); they may or may not involve this specific model.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem99
Appropriate Device Problem Term/Code Not Available80
Loose or Intermittent Connection72
Insufficient Device Problem Information48
Loosening of Implant Not Related to Bone-Ingrowth28
Unstable20
Device Slipped8
Device Markings/Labelling Problem6

Patient problems

Unspecified Infection98
No Code Available63
No Known Impact Or Consequence To Patient53
Insufficient Information44
No Information29
Failure of Implant23
Loss of Range of Motion23
Pain21

Recent adverse event reports

The 25 most recent of 390 reports, in the reporter's own words as published by the FDA.

InjuryApr 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE AFFECTED KNEE FOLLOWING TOTAL KNEE REPLACEMENT SURGERY. APPROXIMATELY 42 MONTHS FOLLOWING INITIAL SURGERY, THE PATIENT UNDERWENT REVISION SURGERY ON THE SAME KNEE.
Patient problems: Ambulation or Postural Difficulties; Limb Pain
MAUDE report 21938299 ↗
InjuryDec 13, 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 TIBIAL SUBSIDENCE. PRIMARY SURGERY OCCURRED ON (B)(6) 2017. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15973110 ↗
InjuryNov 11, 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 ON (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15784226 ↗
InjuryOct 27, 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) 2018. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15685257 ↗
InjuryOct 5, 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 15544088 ↗
InjurySep 9, 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 INSTABILITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15396845 ↗
InjuryJun 24, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS PATELLA RESURFACING. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14806440 ↗
InjuryJun 23, 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 DUE TO LIMITED RANGE OF MOTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Loss of Range of Motion
MAUDE report 14794020 ↗
InjuryJun 15, 2022Unstable
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS MID FLEXION INSTABILITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 14705083 ↗
InjuryJun 12, 2022Appropriate 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: Insufficient Information
MAUDE report 14672623 ↗
InjuryJun 10, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS (10MM-12MM, E-G) HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 14657540 ↗
InjuryJun 5, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS PATELLA RESURFACING. PRIMARY SURGERY OCCURRED ON (B)(6)2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14599716 ↗
InjuryJun 1, 2022Loose or Intermittent Connection; 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, WITH THE SUSPECTED CAUSE BEING THE PATIENT'S HIGH BMI OF 46. PRIMARY SURGERY OCCURRED ON (B)(6) 2015. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14570561 ↗
InjuryMay 28, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS LIMITED RANGE OF MOTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Loss of Range of Motion
MAUDE report 14538665 ↗
InjuryMay 11, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS AND TIBIAL TRAY HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS TIBIAL LOOSENING. PRIMARY SURGERY OCCURRED ON (B)(6) 2017. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14366607 ↗
InjuryMay 8, 2022Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2017. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14332548 ↗
InjuryMay 6, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS DUE TO THE PATIENT EXPERIENCING A QUADRICEPS TEAR, AND THE POLY INSERTS WILL BE EXCHANGED DURING THE PROCEDURE. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Muscle/Tendon Damage
MAUDE report 14311622 ↗
InjuryApr 22, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS (8MM, 10MM, 12MM, 14MM, C, E, G, J) AND TIBIAL TRAY IMPLANT HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS TIBIAL IMPLANT LOOSENING OF UNKNOWN CAUSE. PRIMARY SURGERY OCCURRED ON (B)(6) 2017. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14181058 ↗
InjuryApr 3, 2022Appropriate 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) 2022.
Patient problems: Unspecified Infection
MAUDE report 13992685 ↗
InjuryMar 31, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS DUE TO THE IMPLANT BEING LOOSE AND THE PATELLA IMPLANT HAD COME OFF COMPLETELY. PRIMARY SURGERY OCCURRED ON (B)(6) 2017. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13971443 ↗
InjuryMar 31, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS PATELLA RESURFACING DUE TO THE PATIENT HAVING ANTERIOR KNEE PAIN IN EXTENSION AND DEEP FLEXION. PRIMARY SURGERY OCCURRED ON (B)(6) 2018. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Pain
MAUDE report 13971315 ↗
InjuryMar 9, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS (8MM, 10MM, 12MM, B, D, F) HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2018. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13714984 ↗
InjuryMar 2, 2022Loose or Intermittent Connection; 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) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13656854 ↗
InjuryFeb 27, 2022Loose or Intermittent Connection; 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) 2018. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13615726 ↗
InjuryFeb 2, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS A SUSPECTED INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 13429611 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140423, K142161. One submission often covers many models, so check the product and lot details in each record.

Z-1070-2016 · Jan 28, 2016 · Terminated
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Z-0145-2016 · Aug 31, 2015 · Terminated
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
Z-0141-2016 · Aug 31, 2015 · Terminated
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
Z-0146-2016 · Aug 31, 2015 · Terminated
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
Z-0147-2016 · Aug 31, 2015 · Terminated
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
Z-0144-2016 · Aug 31, 2015 · Terminated
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
Z-0581-2015 · Nov 19, 2014 · Terminated
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.

Device details

UDI-DI	`M572TCR1111111021`
Brand	iTotal® Cruciate Retaining (CR) Knee Replacement System
Model	TCR111111102
Catalog no.	TCR1111111
Company	Conformis, Inc.
Product code	OOG · Knee Arthroplasty Implantation System
Class	Class 2
FDA submission	K140423, K142161
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Total knee prosthesis implantation guide-instrument kit

A collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Components may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components; the implant is not included. This is a single-use device.

Other Knee Arthroplasty Implantation System devices

iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111SPEC02
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11 reports
iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121SPEC02
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11 reports
TRUMATCH 42-0906
Depuy (Ireland) · Knee arthroplasty implantation system
5 reports
iTotal® Identity Cruciate Retaining Knee Replacement System TCR301111301
Conformis, Inc. · Knee Arthroplasty Implantation System
3 reports
iTotal® CR iPoly™ Insert Kit RCR010080003
Conformis, Inc. · Knee Arthroplasty Implantation System
1 report
VISIONAIRE V0200128
Smith & Nephew, Inc. · Knee arthroplasty implantation system
1 report
iTotal Identity CR RCR301111301
Conformis, Inc. · Knee Arthroplasty Implantation System
1 report
ITOTAL IDENTITY IMPACTOR ADAPTER 1080-213
Conformis, Inc. · Knee Arthroplasty Implantation System
1 report

All Knee Arthroplasty Implantation System devices →

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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