iTotal PS TPS-111-111101Recalls & reported problems
Conformis, Inc. · ITOTAL PS IPOLY IMPLANT KIT LEFT or right · Class 2 · Implant
All models of iTotal PS (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Conformis iTotal knee implant is a knee replacement component used in total knee surgery. The 38 reports mostly describe problems that led to repeat operations, including revision surgery to swap out the plastic insert for looseness, pain, infection, or scarring around the joint, plus audible noise from the implant and a ruptured tendon. All 38 reports describe injuries, with 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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI M572TPS1111111011), received between Mar 17, 2016 and Jul 8, 2022 — classified as 38 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (8 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
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Device Operates Differently Than Expected8
- Appropriate Device Problem Term/Code Not Available6
- Noise, Audible6
- Failure To Adhere Or Bond3
- Insufficient Device Problem Information3
- Contamination1
- Loose or Intermittent Connection1
Patient problems
- No Code Available14
- No Known Impact Or Consequence To Patient8
- Unspecified Infection5
- No Information4
- Failure of Implant3
- Loss of Range of Motion3
- Fibrosis1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryJul 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 DUE TO ANOTHER PROCEDURE BEING REQUIRED ON THE AFFECTED JOINT FOR ADHESION REMOVAL, DURING WHICH THE POLY INSERTS WILL BE EXCHANGED. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14961919 ↗InjuryDec 13, 2018Appropriate Device Problem Term/Code Not Available
A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT. REASON FOR REVISION IS UNKNOWN AT THIS TIME.
Patient problems: No Information
MAUDE report 8162586 ↗InjuryDec 11, 2018Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAS LAXITY. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.
Patient problems: No Code Available
MAUDE report 8152842 ↗InjuryAug 29, 2018Insufficient Device Problem Information
IT WAS REPORTED THAT THE SURGEON PLANS TO RESURFACE THE PATELLA. A PROCEDURE IS PLANNED TO RESURFACE THE PATELLA AND EXCHANGE THE POLY INSERT.
Patient problems: No Code Available
MAUDE report 7828265 ↗InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem
THE BILATERAL PATIENT REPORTED PAIN AND POST-OPERATIVE INFECTION IN THE RIGHT KNEE FOLLOWING TOTAL KNEE REPLACEMENT SURGERY.
Patient problems: Pain; Post Operative Wound Infection
MAUDE report 7697963 ↗InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS QUADRICEPS TENDON RUPTURE. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Rupture
MAUDE report 7657861 ↗InjuryJun 14, 2018Device Operates Differently Than Expected; Noise, Audible
IT WAS REPORTED THAT THE PROCEDURE FOR THE DEBRIDEMENT OF SOFT TISSUE WAS PERFORMED FOR A PATIENT WITH AN ITOTAL KNEE REPLACEMENT DUE TO A PATELLA CREPITATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600377 ↗InjuryJun 14, 2018Device Operates Differently Than Expected; Noise, Audible
IT WAS REPORTED THAT THE PROCEDURE FOR THE DEBRIDEMENT OF SOFT TISSUE WAS PERFORMED FOR A PATIENT WITH AN ITOTAL KNEE REPLACEMENT DUE TO A PATELLA CREPITATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600363 ↗InjuryJun 14, 2018Device Operates Differently Than Expected; Noise, Audible
IT WAS REPORTED THAT THE PROCEDURE FOR THE DEBRIDEMENT OF SOFT TISSUE WAS PERFORMED FOR A PATIENT WITH AN ITOTAL KNEE REPLACEMENT DUE TO A PATELLA CREPITATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600354 ↗InjuryJun 14, 2018Device Operates Differently Than Expected; Noise, Audible
IT WAS REPORTED THAT THE PROCEDURE FOR THE DEBRIDEMENT OF SOFT TISSUE WAS PERFORMED FOR A PATIENT WITH AN ITOTAL KNEE REPLACEMENT DUE TO A PATELLA CREPITATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600347 ↗InjuryJun 14, 2018Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PROCEDURE FOR THE DEBRIDEMENT OF SOFT TISSUE WAS PERFORMED FOR A PATIENT WITH AN ITOTAL KNEE REPLACEMENT DUE TO A PATELLA CREPITATION.
Patient problems: No Code Available
MAUDE report 7600346 ↗InjuryJun 14, 2018Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PROCEDURE FOR THE DEBRIDEMENT OF SOFT TISSUE WAS PERFORMED FOR A PATIENT WITH AN ITOTAL KNEE REPLACEMENT DUE TO A PATELLA CREPITATION.
Patient problems: No Code Available
MAUDE report 7600339 ↗InjuryJun 14, 2018Device Operates Differently Than Expected; Noise, Audible
IT WAS REPORTED THAT THE PROCEDURE FOR THE DEBRIDEMENT OF SOFT TISSUE WAS PERFORMED FOR A PATIENT WITH AN ITOTAL KNEE REPLACEMENT DUE TO A PATELLA CREPITATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600338 ↗InjuryJun 14, 2018Device Operates Differently Than Expected; Noise, Audible
IT WAS REPORTED THAT THE PROCEDURE FOR THE DEBRIDEMENT OF SOFT TISSUE WAS PERFORMED FOR A PATIENT WITH AN ITOTAL KNEE REPLACEMENT DUE TO A PATELLA CREPITATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600334 ↗InjuryMay 30, 2018Failure To Adhere Or Bond
IT WAS REPORTED THAT THE PATIENT HAS LAXITY. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: No Code Available
MAUDE report 7553691 ↗InjuryApr 18, 2018Contamination
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 7439393 ↗InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON PLANS TO RESURFACE THE PATELLA. A PROCEDURE IS PLANNED TO RESURFACE THE PATELLA AND EXCHANGE THE POLY INSERT.
Patient problems: No Code Available
MAUDE report 7147369 ↗InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON PLANS TO RESURFACE THE PATELLA. A PROCEDURE IS PLANNED TO RESURFACE THE PATELLA AND EXCHANGE THE POLY INSERT.
Patient problems: No Information
MAUDE report 7048325 ↗InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem
A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT. REASON FOR REVISION IS UNKNOWN AT THIS TIME.
Patient problems: No Code Available
MAUDE report 7048112 ↗InjuryNov 7, 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 INSERT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 7006120 ↗InjuryNov 6, 2017Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS LAXITY OF THE COLLATERAL LIGAMENTS. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Failure of Implant
MAUDE report 7003203 ↗InjurySep 7, 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 INSERT.
Patient problems: Unspecified Infection
MAUDE report 6847884 ↗InjuryAug 22, 2017Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS LIMITED RANGE OF MOTION. A PROCEDURE IS PLANNED TO PERFORM AN OPEN DEBRIDEMENT AND TO EXCHANGE THE POLY INSERT.
Patient problems: Loss of Range of Motion
MAUDE report 6809508 ↗InjuryAug 15, 2017Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAS LAXITY. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: No Code Available
MAUDE report 6793700 ↗InjuryJun 21, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS LIMITED RANGE OF MOTION DUE TO ARTHROFIBROSIS. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Fibrosis; Loss of Range of Motion
MAUDE report 6656318 ↗
Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
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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