iTotal Cruciate Retaining (CR) Knee Replacement SystemRecalls & reported problems across all models
Conformis, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 562
- Deaths reported
- 0
- Injuries reported
- 539
- Recalls
- 0
We found 4 models of iTotal Cruciate Retaining (CR) Knee Replacement System by Conformis, Inc. in the FDA's device registry (GUDID). Together they are named in 562 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2016 and Apr 30, 2025 — classified as 539 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (107 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 Cruciate Retaining (CR) Knee Replacement System problems
Device problems
- Adverse Event Without Identified Device or Use Problem149
- Appropriate Device Problem Term/Code Not Available123
- Loose or Intermittent Connection107
- Insufficient Device Problem Information65
- Loosening of Implant Not Related to Bone-Ingrowth36
- Unstable28
- Device Dislodged or Dislocated9
- Device Slipped8
Patient problems
- Unspecified Infection155
- No Code Available85
- No Known Impact Or Consequence To Patient78
- Insufficient Information60
- No Information36
- Failure of Implant35
- Loss of Range of Motion31
- Pain27
iTotal Cruciate Retaining (CR) Knee Replacement System models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111111102Knee Arthroplasty Implantation System390 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111SPEC02Knee Arthroplasty Implantation System11 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121SPEC02Knee Arthroplasty Implantation System11 reports
Recent iTotal Cruciate Retaining (CR) 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.
InjuryApr 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE AFFECTED KNEE FOLLOWING TOTAL KNEE REPLACEMENT SURGERY. APPROXIMATELY 42 MONTHS FOLLOWING INITIAL SURGERY, THE PATIENT UNDERWENT REVISION SURGERY ON THE SAME KNEE.
Patient problems: Ambulation or Postural Difficulties; Limb Pain
MAUDE report 21938299 ↗InjuryDec 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 TIBIAL SUBSIDENCE. PRIMARY SURGERY OCCURRED ON (B)(6) 2017. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15973110 ↗InjuryNov 11, 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 ON (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15784226 ↗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) 2018. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15685257 ↗InjuryOct 5, 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 15544088 ↗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 ↗InjurySep 9, 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) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15396845 ↗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 24, 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) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14806440 ↗InjuryJun 23, 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 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 14794020 ↗InjuryJun 15, 2022Unstable
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS MID FLEXION INSTABILITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 14705083 ↗InjuryJun 12, 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. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14672623 ↗InjuryJun 10, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS (10MM-12MM, E-G) 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 14657540 ↗
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 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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