iTotal® PS TPS111111102Recalls & reported problems

Conformis, Inc. · iTotal® Posterior Stabilized (PS) Knee Replacement System · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Conformis iTotal PS knee replacement is a knee implant. Its 327 reports describe implants that loosened or became unstable, infections, and limited range of motion, and some describe revision surgery to replace plastic inserts. The reports include no deaths and 316 injuries. 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: 327
Deaths reported: 0
Injuries reported: 316
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 327 adverse event reports that list this exact device (DI M572TPS1111111021), received between Sep 13, 2016 and Nov 10, 2022 — classified as 316 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (42 reports).

1 other recall cover devices cleared under the same FDA submission (K160025); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Appropriate Device Problem Term/Code Not Available95
Adverse Event Without Identified Device or Use Problem89
Loose or Intermittent Connection42
Insufficient Device Problem Information29
Loosening of Implant Not Related to Bone-Ingrowth21
Unstable13
Device Slipped7
Noise, Audible5

Patient problems

Unspecified Infection93
Insufficient Information49
No Code Available47
No Known Impact Or Consequence To Patient46
Failure of Implant25
Loss of Range of Motion21
Pain14
Joint Laxity11

Recent adverse event reports

The 25 most recent of 327 reports, in the reporter's own words as published by the FDA.

InjuryNov 10, 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) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 15776191 ↗
InjuryNov 10, 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 AN INFECTION OF UNKNOWN CAUSE. PRIMARY SURGERY OCCURRED ON (B)(6) 2018. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 15775604 ↗
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) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15684324 ↗
InjuryOct 6, 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) 2019. REVISION SURGERY DATE IS UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 15556596 ↗
InjurySep 30, 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 PATELLA RESURFACING. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15514189 ↗
InjurySep 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 LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15463386 ↗
InjurySep 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) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 15463254 ↗
InjurySep 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 LIMITED RANGE OF MOTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Loss of Range of Motion
MAUDE report 15463144 ↗
InjurySep 16, 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 DUE TO AN INFECTION THAT DEVELOPED SOMEWHERE IN THE PATIENTS BODY AND SETTLED IN THE KNEE. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 15442306 ↗
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 15374699 ↗
InjuryAug 17, 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 PATELLA RESURFACING. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15245465 ↗
InjuryJul 22, 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 LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15090155 ↗
InjuryJul 21, 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) 2017. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 15080717 ↗
InjuryJul 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 PATELLA RESURFACING. PRIMARY SURGERY OCCURRED ON (B)(6) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 15024606 ↗
InjuryJul 13, 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) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 15008343 ↗
InjuryJul 10, 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) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14973861 ↗
InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS (11MM) 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 14649326 ↗
InjuryJun 1, 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) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14570460 ↗
InjuryMay 27, 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) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14525061 ↗
InjuryMay 26, 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. ORIGINAL SURGERY OCCURRED ON (B)(6) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14519981 ↗
InjuryMay 21, 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 FALLING ON HER KNEE. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Fall
MAUDE report 14466511 ↗
InjuryMay 21, 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 DUE TO EXCESSIVE TIBIAL RESECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2018. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 14466259 ↗
InjuryMay 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 A SUSPECTED INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14403417 ↗
InjuryMay 11, 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 14366530 ↗
InjuryMay 8, 2022Appropriate 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 OF UNKNOWN CAUSE. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14332550 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160025. One submission often covers many models, so check the product and lot details in each record.

Z-0658-2017 · Oct 18, 2016 · Terminated
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pa

Device details

UDI-DI	`M572TPS1111111021`
Brand	iTotal® PS
Model	TPS111111102
Catalog no.	TPS1111111
Company	Conformis, Inc.
Product code	OIY · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Class	Class 2
FDA submission	K160025
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Aug 15, 2022

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

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
iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102
Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
150 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 1516-40-605
Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
120 reports
ATTUNE 1506-70-006
Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
1 recall70 reports
DJO SURGICAL 342-10-706
Encore Medical, L.P. · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
1 recall69 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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