iTotal Identity Cruciate Retaining Knee Replacement SystemRecalls & reported problems across all models
Conformis, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 75
- Deaths reported
- 0
- Injuries reported
- 74
- Recalls
- 0
We found 4 models of iTotal Identity Cruciate Retaining Knee Replacement System by Conformis, Inc. in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2019 and May 7, 2026 — classified as 74 injuries, 1 malfunction.
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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported iTotal Identity Cruciate Retaining Knee Replacement System problems
Device problems
- Appropriate Device Problem Term/Code Not Available45
- Adverse Event Without Identified Device or Use Problem13
- Loose or Intermittent Connection6
- Loosening of Implant Not Related to Bone-Ingrowth4
- Insufficient Device Problem Information3
- Break1
- Contamination /Decontamination Problem1
- Fitting Problem1
Patient problems
- Insufficient Information20
- Unspecified Infection19
- Joint Laxity9
- Loss of Range of Motion8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions2
- Scar Tissue2
iTotal Identity Cruciate Retaining Knee Replacement System models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iTotal® Identity Cruciate Retaining Knee Replacement System TCR101111201Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive69 reports
- iTotal® Identity Cruciate Retaining Knee Replacement System TCR301111301Knee Arthroplasty Implantation System3 reports
- iTotal® Identity Cruciate Retaining Knee Replacement System TCR000D00101Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2 reports
- iTotal® Identity Cruciate Retaining Knee Replacement System TCR020070001Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive1 report
Recent iTotal Identity Cruciate Retaining Knee Replacement System adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryNov 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PATIENT IS HAVING REVISION PROCEDURE TO ADDRESS TIBIAL COMPONENT LOOSENING FROM (B)(6) 2025 TOTAL KNEE REPLACEMENT.
Patient problems: Aseptic loosening
MAUDE report 23657871 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT INDICATED OVER THE PHONE THAT THEY HAD ONGOING PAIN. PATIENT HAD A REVISION OF THEIR (B)(6) 2024 IMPLANT ON (B)(6) 2025 TO HAVE A POLY SWAP WITH A DIFFERENT THICKNESS.
Patient problems: Joint Laxity
MAUDE report 23458736 ↗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 ↗
Other Conformis, Inc. products
All Conformis, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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