iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Recalls & 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 system is a knee implant. Its 150 reports mostly describe patients who needed revision surgery to replace the plastic insert, for reasons such as looseness or infection. The reports include 146 injuries and no deaths. 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: 150
Deaths reported: 0
Injuries reported: 146
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI M572TCR1211111021), received between Aug 15, 2016 and Oct 4, 2022 — classified as 146 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (33 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.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem41
Appropriate Device Problem Term/Code Not Available37
Loose or Intermittent Connection33
Insufficient Device Problem Information16
Loosening of Implant Not Related to Bone-Ingrowth8
Unstable7
Device Dislodged or Dislocated4
Contamination2

Patient problems

Unspecified Infection46
No Known Impact Or Consequence To Patient24
No Code Available19
Insufficient Information15
Failure of Implant10
No Information7
Loss of Range of Motion6
Pain5

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

InjuryOct 4, 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) 2017. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15536654 ↗
InjuryJul 30, 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) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 15136797 ↗
InjuryJul 3, 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 POLY INSERT LOOSENING. PRIMARY SURGERY OCCURRED ON (B)(6) 2019. REVISION SURGERY DATE IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 14902311 ↗
InjuryJun 30, 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 AN INFECTION OF UNKNOWN CAUSE. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14880315 ↗
InjuryJun 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 INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14605644 ↗
InjuryMay 28, 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 14538664 ↗
InjuryMay 11, 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 WASH-OUT AND POLY SWAP DUE TO A SUSPECTED INFECTION OF UNKNOWN CAUSE. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14366611 ↗
InjuryMay 4, 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 SYNOVECTOMY DURING WHICH THE POLY INSERTS WILL BE EXCHANGED. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14272843 ↗
InjuryApr 22, 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) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14181090 ↗
InjuryApr 13, 2022Unstable
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS DUE TO PATIENT FALL AND EXPERIENCING INSTABILITY AS A RESULT. PRIMARY SURGERY OCCURRED ON (B)(6) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 14106970 ↗
InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED 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: Bacterial Infection
MAUDE report 13586636 ↗
InjuryJan 14, 2022Appropriate 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: Insufficient Information
MAUDE report 13261428 ↗
InjuryDec 8, 2021Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS UNKNOWN AT THIS TIME. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 12964162 ↗
InjuryNov 19, 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) 2017. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Unspecified Infection
MAUDE report 12848599 ↗
InjuryNov 17, 2021Insufficient Device Problem Information
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS AND A TIBIAL TRAY KIT HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS UNKNOWN AT THIS TIME. PRIMARY SURGERY OCCURRED ON (B)(6) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 12832378 ↗
InjuryOct 22, 2021Insufficient Device Problem Information
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) 2021.
Patient problems: Joint Laxity
MAUDE report 12685386 ↗
InjuryOct 21, 2021Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS AND A REPLACEMENT TIBIAL TRAY KIT HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS DUE TO TIBIAL LOOSENING. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Joint Laxity
MAUDE report 12675853 ↗
InjuryAug 10, 2021Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS BECAUSE THE PATIENT HAS ARTHROFIBROSIS AND REQUIRES A CLEAN UP AND POLY INSERT SWAP. PRIMARY SURGERY OCCURRED ON (B)(6) 2018. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Fibrosis
MAUDE report 12301336 ↗
InjuryJul 31, 2021Loose 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 ATTRIBUTED TO PATIENT LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 12257213 ↗
InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY DATE IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12221539 ↗
InjuryJul 7, 2021Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT HAD TIBIAL LOOSENING. THE CAUSE FOR THE LOOSENING IS UNKNOWN. REVISION SURGERY IS PLANNED TO ADDRESS THE ISSUE AND EXCHANGE THE POLY INSERTS.
Patient problems: Insufficient Information
MAUDE report 12132116 ↗
InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. REVISION SURGERY IS PLANNED TO ADDRESS THE ISSUE AND EXCHANGE THE POLY INSERTS.
Patient problems: Unspecified Infection
MAUDE report 12110213 ↗
InjuryJul 2, 2021Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAS DEVELOPED LAXITY OVER TIME AND REQUIRES POLY INSERTS OF A DIFFERENT THICKNESS. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: Insufficient Information
MAUDE report 12110208 ↗
InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS A SUSPECTED INFECTION. REVISION SURGERY IS PLANNED TO ADDRESS THE ISSUE AND EXCHANGE THE POLY INSERTS.
Patient problems: Unspecified Infection
MAUDE report 12108417 ↗
InjuryJun 17, 2021Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAD KNEE PAINS SINCE RECEIVING THEIR IMPLANT. THE PATIENT WENT TO A NON-CONFORMIS SURGEON WHERE THEIR IMPLANT WAS EXPLANTED AND A FULL TKA REVISION TOOK PLACE. THE REVISING SURGEON CONCLUDED THAT THE CONFORMIS KNEE WAS "NOT WORKING PROPERLY AS IT SHOULD".
Patient problems: Pain
MAUDE report 12021615 ↗

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-0146-2016 · Aug 31, 2015 · Terminated
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
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-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-0141-2016 · Aug 31, 2015 · Terminated
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (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-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	`M572TCR1211111021`
Brand	iTotal® Cruciate Retaining (CR) Knee Replacement System
Model	TCR121111102
Catalog no.	TCR1211111
Company	Conformis, Inc.
Product code	OIY · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive devices

iTotal® PS TPS111111102
Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
327 reports
ATTUNE 1506-00-006
Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
287 reports
ATTUNE 1506-00-008
Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
233 reports
ATTUNE 1506-70-007
Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
1 recall2 deaths74 reports
ATTUNE 1516-40-506
Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
121 reports
ATTUNE 1506-70-006
Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
1 recall70 reports
ATTUNE 1516-40-605
Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
120 reports
ATTUNE 1516-40-505
Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
119 reports

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive 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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