iTotal Identity Posterior Stabilized Knee Replacement System TPS101111201Recalls & reported problems
Conformis, Inc. · ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED) · Class 2 · Implant
All models of iTotal Identity Posterior Stabilized Knee Replacement System (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Conformis iTotal Identity knee femoral implant is part of a cemented knee replacement system. The 25 reports mention 25 injuries and no deaths, mostly describing infections and loose joints that led to requests for replacement parts for revision surgery, with a few mentioning packaging or sterility problems that delayed or cancelled procedures. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI M572TPS1011112011), received between Jul 7, 2021 and Jan 31, 2023 — classified as 25 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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, 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
- Appropriate Device Problem Term/Code Not Available18
- Adverse Event Without Identified Device or Use Problem6
- Loose or Intermittent Connection1
- Unstable1
Patient problems
- Unspecified Infection11
- Insufficient Information6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Joint Laxity3
- Failure of Implant1
- Fall1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryJan 6, 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. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 13177875 ↗InjuryDec 23, 2021Appropriate 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) 2021.
Patient problems: Insufficient Information
MAUDE report 13082794 ↗InjuryDec 1, 2021Appropriate 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) 2021.
Patient problems: Unspecified Infection
MAUDE report 12914272 ↗InjuryOct 28, 2021Appropriate 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 12716501 ↗InjuryOct 22, 2021Adverse 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) 2020. REVISION SURGERY DATE IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 12685268 ↗InjuryOct 1, 2021Appropriate 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 PATIENT FALL. PRIMARY SURGERY OCCURRED ON (B)(6)2021. REVISION SURGERY PLANNED DATE IS UNKNOWN.
Patient problems: Fall
MAUDE report 12565182 ↗InjuryAug 5, 2021Loose 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 DUE TO PATIENT LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY PLANNED DATE IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12281277 ↗InjuryJul 31, 2021Appropriate 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 PLANNED DATE IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12257211 ↗InjuryJul 23, 2021Adverse 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) 2021.
Patient problems: Unspecified Infection
MAUDE report 12220903 ↗InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY DATE IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12220865 ↗InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE CAUSE FOR INFECTION IS UNKNOWN. REVISION SURGERY IS PLANNED TO ADDRESS THE ISSUE BY PERFORMING A WASHOUT AND EXCHANGING THE POLY INSERTS.
Patient problems: Unspecified Infection
MAUDE report 12206840 ↗InjuryJul 7, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT. REASON FOR REVISION IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 12132101 ↗
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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