iTotal® Identity Cruciate Retaining Knee Replacement System TCR101111201Recalls & reported problems
Conformis, Inc. · ITOTAL IDENTITY CR FEMORAL IMPLANT (COCR, CEMENTED) · Class 2 · Implant
All models of iTotal Identity Cruciate Retaining Knee Replacement System (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Conformis iTotal Identity knee replacement is an implant used to replace a worn knee joint while keeping the patient's own ligaments. The 69 reports mostly describe pain and complications after surgery — infection, a loose or unstable joint, limited range of motion, and scarring — and several patients needing revision surgery to replace the plastic insert. No deaths were reported, and all 69 reports were injuries.
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
- 69
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI M572TCR1011112011), received between Nov 11, 2019 and May 7, 2026 — classified as 69 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (6 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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available44
- Adverse Event Without Identified Device or Use Problem12
- Loose or Intermittent Connection6
- Loosening of Implant Not Related to Bone-Ingrowth3
- Insufficient Device Problem Information2
- Contamination /Decontamination Problem1
- Fitting Problem1
- Material Too Rigid or Stiff1
Patient problems
- Insufficient Information19
- Unspecified Infection19
- Joint Laxity8
- Loss of Range of Motion7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions2
- Scar Tissue2
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Positioning Failure
IT WAS REPORTED THAT THE TIBIAL IMPLANT OF A TOTAL KNEE SYSTEM WAS IMPLANTED IN SUCH A WAY THAT THERE WAS INTERFERENCE BETWEEN THE DEVICE AND A SCREW IN THE PATELLAR TENDON, SUGGESTING THAT THERE WAS EXCESSIVE SLOPE IN THE WAY THE TIBIAL IMPLANT WAS IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion
MAUDE report 25116584 ↗InjuryFeb 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
REPLACEMENT POLY INSERTS WERE ORDERED FOR REVISION SURGERY DUE TO INFECTION. THE ORIGINAL SURGERY WAS (B)(6)2022 AND THE REVISION SURGERY WAS(B)(6)2023. THE CAUSE OF THE INFECTION IS UNKNOWN
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16399528 ↗InjuryFeb 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REVISION SURGERY WAS NEEDED AFTER THE PATIENT DEVELOPED AN INFECTION AFTER THE PRIMARY SURGERY. THE ORIGINAL SURGERY DATE WAS (B)(6) 2022. THE REVISION SURGERY WAS (B)(6) 2023.
Patient problems: Medical device site infection
MAUDE report 16398112 ↗InjuryNov 28, 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) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 15874570 ↗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 DUE TO LIMITED RANGE OF MOTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Loss of Range of Motion
MAUDE report 15776225 ↗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 15685392 ↗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) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15556462 ↗InjurySep 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 INSTABILITY. 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 15414690 ↗InjurySep 3, 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 LOOSENING. 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 15353670 ↗InjurySep 3, 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 A POLY SWAP OF UNKNOWN REASON. 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 15353668 ↗InjuryAug 14, 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 A SUSPECTED INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 15223070 ↗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 DATE IS UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 15090151 ↗InjuryJul 19, 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) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 15061456 ↗InjuryJul 19, 2022Migration or Expulsion of Device; 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 TRAY SUBSIDENCE. PRIMARY SURGERY OCCURRED ON (B)(6) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 15061445 ↗InjuryJul 17, 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 DATE IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 15036880 ↗InjuryJun 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 AN INFECTION OF UNKNOWN CAUSE. PRIMARY SURGERY OCCURRED ON (B)(6) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14880387 ↗InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS (6MM, A) 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 14649338 ↗InjuryMay 29, 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) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14539097 ↗InjuryMay 20, 2022Unexpected Therapeutic Results
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS MEDIAL AND LATERAL LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 14458810 ↗InjuryApr 24, 2022Appropriate Device Problem Term/Code Not Available; Loosening 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) 2022. REVISION SURGERY DATE IS UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 14191440 ↗InjuryApr 6, 2022Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. A SECOND POLY INSERT ORDER WAS PLACED ON THE FOLLOWING DAY ((B)(6) 2022) FOR THE SAME PARTS WITH TRIALS. 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 14034802 ↗InjuryApr 6, 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) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 14034693 ↗InjuryApr 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 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 13985449 ↗InjuryMar 17, 2022Appropriate 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) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13792858 ↗InjuryMar 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) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 13664567 ↗
Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive devices
- iTotal® PS TPS111111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive327 reports
- ATTUNE 1506-00-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive287 reports
- ATTUNE 1506-00-008Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive233 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- ATTUNE 1506-70-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall2 deaths74 reports
- ATTUNE 1516-40-506Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive121 reports
- ATTUNE 1506-70-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall70 reports
- ATTUNE 1516-40-605Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive120 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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