iTotal® Posterior Stabilized (PS) Knee Replacement System TPS121111102Recalls & reported problems
Conformis, Inc. · ITOTAL PS–IPOLY XE–IMPLANT KIT–LEFT or right · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Conformis iTotal knee replacement system is a knee implant with a rotating insert. Most of the 45 reports describe knee instability, infection, or the implant loosening, with several patients needing revision surgery to swap out the plastic insert. There were 42 injuries and no deaths. 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
- 45
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI M572TPS1211111021), received between Jun 6, 2018 and Jun 30, 2022 — classified as 42 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (11 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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available14
- Loose or Intermittent Connection11
- Adverse Event Without Identified Device or Use Problem10
- Loosening of Implant Not Related to Bone-Ingrowth4
- Difficult or Delayed Positioning2
- Collapse1
- Connection Problem1
- Device-Device Incompatibility1
Patient problems
- Unspecified Infection14
- No Known Impact Or Consequence To Patient8
- Insufficient Information7
- Failure of Implant3
- Joint Laxity3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Loss of Range of Motion2
- Scar Tissue2
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 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 LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Joint Laxity
MAUDE report 14879973 ↗InjuryApr 13, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. THE PATIENT WILL BE REVISED TO HAVE SCAR TISSUE REMOVED FROM THE PATELLA WHICH HAS CAUSED LAXITY IN THE KNEE. PRIMARY SURGERY OCCURRED ON (B)(6) 2016. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Scar Tissue
MAUDE report 14107027 ↗InjuryApr 13, 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 14107001 ↗InjuryMar 15, 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) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13776649 ↗InjuryFeb 18, 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) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13564460 ↗InjuryDec 5, 2021Appropriate 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) 2021.
Patient problems: Joint Laxity
MAUDE report 12931767 ↗InjurySep 22, 2021Loose or Intermittent Connection
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 IS PLANNED FOR (B)(6) 2021.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 12515514 ↗InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT REVISION SURGERY IS NECESSARY FOR UNKNOWN REASON. ORIGINAL SURGERY: (B)(6) 2020. REVISION SURGERY PLANNED: (B)(6) 2021.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12379605 ↗InjuryAug 5, 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 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 12281191 ↗InjuryJun 3, 2021Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS SCAR TISSUE BUILD-UP AND REQUIRES LYSIS OF ADHESIONS. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Scar Tissue
MAUDE report 11935034 ↗InjuryMar 30, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAD LAXITY OF AN UNKNOWN CAUSE. REVISION SURGERY OCCURRED WHERE THE SURGEON EXCHANGED THE PATIENT'S 6MM POLY INSERT FOR AN 8MM INSERT.
Patient problems: Insufficient Information
MAUDE report 11593082 ↗InjuryFeb 8, 2021Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT HAS LAXITY IN THEIR KNEE AND REQUIRES A POLY INSERT OF A DIFFERENT THICKNESS. THE SURGEON DOES NOT HAVE A SUSPECTED CAUSE FOR THE LAXITY. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Insufficient Information
MAUDE report 11298453 ↗InjuryFeb 8, 2021Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT HAS LAXITY AND REQUIRES A POLY INSERT OF DIFFERENT THICKNESS. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Insufficient Information
MAUDE report 11298434 ↗MalfunctionJan 27, 2021Difficult or Delayed Positioning
IT WAS REPORTED THAT THE FEMORAL IMPLANT WAS NOT SITTING FLUSH TO THE SURGEON'S EXPECTATIONS. THERE WAS OVERHANG ON THE LATERAL SIDE AND IT APPEARED TO NEED MEDIAL ROTATION. THE SURGEON ATTEMPTED TO REPOSITION THE FEMORAL LUG HOLES, BUT COULD NOT SHIFT THEM ANY FURTHER. THE SURGERY WAS COMPLETED SUCCESSFULLY, BUT WITH A 15 TO 20 MINUTE DELAY IN THE PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11240792 ↗MalfunctionJan 27, 2021Difficult or Delayed Positioning
IT WAS REPORTED THAT THE SURGEON HAD ISSUES WITH THE POSITIONING OF THE F4 IJIG. THE ROTATION OF THE JIG APPEARED TO BE OFF WHICH RESULTED IN SOME OVERHANG OF THE FEMORAL IMPLANT. THE SURGEON REPEATED PLACEMENT OF THE F2 AND F3 TO DRILL THE DISTAL HOLES FOR THE F4 RESULTING IN A BETTER POSITIONING FOR THE F4. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11240763 ↗InjuryJan 15, 2021Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS LOST RANGE OF MOTION IN FLEXION AND NEEDS A THINNER POLY INSERT. THE SURGEON IS INSURE WHAT THE CAUSE FOR THIS ISSUE IS. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Loss of Range of Motion
MAUDE report 11181602 ↗InjuryDec 15, 2020Collapse
IT WAS REPORTED THAT THE PATIENT'S TIBIA COLLAPSED UNDER THE IMPLANT DUE TO SOFT BONE WITHIN THEIR TIBIA. REVISION SURGERY IS PLANNED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant
MAUDE report 11007842 ↗InjuryNov 30, 2020Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT HAS LAXITY AND REQUIRES A POLY INSERT OF A DIFFERENT THICKNESS. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Insufficient Information
MAUDE report 10923688 ↗InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Unspecified Infection
MAUDE report 10923239 ↗InjuryNov 3, 2020Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT HAS LAXITY AND REQUIRES REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Insufficient Information
MAUDE report 10782070 ↗InjuryOct 22, 2020Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. THE ORIGIN OF THE INFECTION IS UNKNOWN. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Unspecified Infection
MAUDE report 10717714 ↗InjurySep 8, 2020Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT'S JOINT BECAME LOOSE AND REQUIRES A POLY INSERT OF A THICKER SIZE. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Failure of Implant; Therapeutic Effects, Unexpected
MAUDE report 10504528 ↗InjuryAug 11, 2020Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT HAS LIMITED RANGE OF MOTION AND REQUIRES A REPLACEMENT INSERT OF A DIFFERENT THICKNESS. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Loss of Range of Motion
MAUDE report 10393059 ↗InjuryJul 23, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS LAXITY AND REQUIRES A POLY INSERT OF A DIFFERENT THICKNESS. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10317922 ↗InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Unspecified Infection
MAUDE report 10280126 ↗
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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