iTotal Identity Posterior Stabilized Knee Replacement SystemRecalls & reported problems across all models
Conformis, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 0
We found 3 models of iTotal Identity Posterior Stabilized Knee Replacement System by Conformis, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2021 and Oct 17, 2025 — classified as 27 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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 Posterior Stabilized Knee Replacement System problems
Device problems
- Appropriate Device Problem Term/Code Not Available18
- Adverse Event Without Identified Device or Use Problem7
- Improper or Incorrect Procedure or Method1
- Loose or Intermittent Connection1
- Unstable1
Patient problems
- Unspecified Infection11
- Insufficient Information7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Joint Laxity3
- Failure of Implant1
- Fall1
- Limb Pain1
iTotal Identity Posterior Stabilized Knee Replacement System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iTotal Identity Posterior Stabilized Knee Replacement System TPS101111201Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer25 reports
- iTotal Identity Posterior Stabilized Knee Replacement System TPS010060001Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- iTotal Identity Posterior Stabilized Knee Replacement System TPS301111301Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Recent iTotal Identity Posterior Stabilized 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.
InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED TO THE SURGEON WITH KNEE INSTABILITY. A REVISION POLY HAS BEEN REQUESTED FOR ADDITIONAL CONSTRAINT.
Patient problems: Limb Pain
MAUDE report 23327789 ↗InjuryJan 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE SURGEON HAS ORDERED THE FOLLOWING REPLACEMENT PARTS FOR INTENDED REVISION SURGERY. ITOTAL IDENTITY PS TIBIAL INSERT 10MM RIGHT. ITOTAL IDENTITY PS TIBIAL INSERT,, 6MM, RIGHT. ITOTAL IDENTITY PS TIBIAL INSERT, 8MM, RIGHT. ORIGINAL SURGERY DATE: (B)(6) 2022. NEW SURGERY DATE: (B)(6) 2023.
Patient problems: Unspecified Infection
MAUDE report 16273374 ↗InjuryNov 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING SURGERY A HOLE WAS DISCOVERED IN THE IDENTITY PS FEMUR PACKAGING FOR SN (B)(4). THIS BREACH WAS DISCOVERED AFTER DR. JOHNSON HAD FINISHED MOST OF THE FEMORAL IMPLANT RESECTIONS, BARRING THE BOX RESECTION. AFTER DISCOVERING THE PACKAGING BREACH, THEY MADE A DECISION TO BAIL ON THE PROCEDURE AND MOVE TO ZIMMER. THIS CAUSED A 30 MINUTE+ DELAY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15739401 ↗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) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 15684623 ↗InjurySep 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT WHILE OPENING THE JIGS, A PIECE OF HAIR WAS FOUND INSIDE THE STERILE POUCH. THE CASE WAS IMMEDIATELY CANCELLED. THE PATIENT WAS UNDERGOING SPINAL PAIN BLOCK PROCEDURE WHILE THIS ISSUE WAS DISCOVERED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15480988 ↗InjurySep 19, 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 15451701 ↗InjurySep 19, 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 POSSIBLE INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 15451671 ↗InjurySep 8, 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) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022
Patient problems: Joint Laxity
MAUDE report 15384873 ↗InjuryAug 19, 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 06/21/2022. REVISION SURGERY DATE IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 15262854 ↗InjuryAug 18, 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 15254463 ↗InjuryJun 3, 2022Unstable
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS FLEXION INSTABILITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY DATE IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 14598321 ↗InjuryMay 8, 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 14332376 ↗InjuryMar 22, 2022Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT IN THE RECEIVED KIT, THE TRIAL TIBIAL BASE PLATE WAS PS BUT THE REAL TIBIAL BASE PLATE IMPLANTED WAS A CR. ALL POLY INSERTS WERE PS. THE PATIENT HAD TO UNDERGO REVISION SURGERY TO CORRECT THIS. ORIGINAL SURGERY WAS ON (B)(6) 2022. REVISION SURGERY WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13850953 ↗InjuryFeb 2, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED 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 13429999 ↗InjuryJan 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 INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Unspecified Infection
MAUDE report 13200968 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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