iUni iPoly Implant UKA-111-111103Recalls & reported problems
Conformis, Inc. · IUNI–IPOLY–IMPLANT KIT–RIGHT or Left LATERAL or medial · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Conformis iUni iPoly implant is a knee replacement insert used in partial knee replacement surgery. The 33 adverse event reports mostly describe patients who later needed revision surgery to exchange the plastic insert or other parts, because of infection, pain, looseness of the implant, or the knee feeling unstable; 28 reports involved injuries and there were 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
- 33
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI M572UKA1111111031), received between Sep 22, 2016 and Oct 27, 2022 — classified as 28 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 Available7
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information4
- Loosening of Implant Not Related to Bone-Ingrowth4
- Device Slipped3
- Device Dislodged or Dislocated2
- Device Operates Differently Than Expected2
- Fitting Problem2
Patient problems
- Unspecified Infection9
- No Known Impact Or Consequence To Patient7
- Pain6
- Insufficient Information3
- No Code Available3
- No Information2
- Failure of Implant1
- Joint Dislocation1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
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 INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2019. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 15685104 ↗InjuryJul 31, 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 15136905 ↗InjurySep 30, 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 THE PATIENT HAVING POSTERIOR LATERAL PAIN. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Pain
MAUDE report 12557685 ↗InjurySep 3, 2021Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT REPLACEMENT POLY INSERTS AND A TIBIAL TRAY KIT HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS DUE TO PATIENT LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 12425126 ↗InjuryMar 30, 2021Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS A POSSIBLE INFECTION OF AN UNKNOWN CAUSE. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Unspecified Infection
MAUDE report 11593078 ↗InjuryNov 3, 2020Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Unspecified Infection
MAUDE report 10781934 ↗InjuryOct 20, 2020Appropriate 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 10708105 ↗InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS PAIN. THE SURGEON BELIEVES THERE IS POSSIBLE LOOSENING OF THEIR TIBIAL BASEPLATE, BUT HAS NOT CONFIRMED IT. REVISION SURGERY IS PLANNED TO ADDRESS THE ISSUE.
Patient problems: Pain
MAUDE report 10136002 ↗InjuryApr 21, 2020Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAS LAXITY. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: No Code Available
MAUDE report 9982560 ↗InjuryAug 21, 2019Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A CONFORMIS IUNI PATIENT WAS REVISED TO AN OFF-THE-SHELF TOTAL KNEE DUE TO TIBIAL LOOSENING. THE SURGEON PRESUMED IT WAS A CEMENT ISSUE RATHER THAN THE IMPLANT ITSELF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8915754 ↗InjuryJun 7, 2019Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAS LAXITY. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8678492 ↗InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Unspecified Infection
MAUDE report 7717663 ↗InjuryMay 23, 2018Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT IS CLINICALLY UNSTABLE. IT WAS ALSO REPORTED THAT THE 6 MM POLY INSERT ORIGINALLY IMPLANTED IS TOO SMALL. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7537637 ↗InjuryMay 16, 2018Positioning Problem
IT WAS REPORTED THAT THE SURGEON IS NOT SATISFIED WITH THE PLACEMENT OF THE TIBIAL TRAY. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT AND TIBIAL TRAY.
Patient problems: No Information
MAUDE report 7517782 ↗InjuryMar 28, 2018Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT HAS FEMORAL AND TIBIAL LOOSENING. A REVISION SURGERY IS PLANNED TO EXCHANGE THE FEMORAL IMPLANT, POLY INSERT AND TIBIAL TRAY.
Patient problems: Failure of Implant
MAUDE report 7376916 ↗InjuryJan 26, 2018Difficult or Delayed Positioning
IT WAS REPORTED THAT THE SURGEON DIDN'T FEEL LIKE THE SIZE FEMORAL COMPONENT COVERED THE CONDYLE OF THE FEMUR ENOUGH. THERE WAS ARTICULAR CARTILAGE THAT SHOWED WEAR SUPERIOR TO THE TOP OF THE IMPLANT. THEY FELT THAT THE IMPLANT SHOULD HAVE EXTENDED HIGH ENOUGH TO COVER THAT AREA. PATIENT WAS CONVERTED INTRAOPERATIVELY TO A OTS TOTAL KNEE. THE CASE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Code Available
MAUDE report 7222949 ↗InjuryJan 24, 2018Insufficient Device Problem Information
THE PATIENT REPORTED THAT HE IS HAVING AN ISSUES WITH HIS IUNI REPLACEMENT FOLLOWING THE PRIMARY SURGERY. THE PATIENT REPORTED THAT HE IS EXPERIENCING PAIN. THE SURGERIES TO REMOVE PLICA OCCURRED.
Patient problems: Pain
MAUDE report 7214753 ↗InjuryDec 27, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE 8 MM POLY INSERT WOULD NOT ENGAGE ON POSTERIOR LIP. THE 6 MM POLY INSERT WAS IMPLANTED TO COMPLETE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7148614 ↗InjuryDec 13, 2017Device Slipped; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAS SLIPPAGE AND LOOSE OR DISLOCATED POLY INSERT. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Joint Dislocation
MAUDE report 7112199 ↗MalfunctionDec 13, 2017Fitting Problem
IT WAS REPORTED THAT THE 8 MM POLY INSERT WOULD NOT FIT INTO THE TIBIAL TRAY. THE 6 MM POLY INSERT WAS IMPLANTED TO COMPLETE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7112184 ↗MalfunctionNov 8, 2017Device Slipped
IT WAS REPORTED THAT THE 8 MM AND 6 MM POLY INSERTS PROVIDED WITH THE KIT WOULD NOT LOCK INTO THE TIBIAL TRAY. AFTER GOING BACK AND FORTH BETWEEN THE TWO SIZE POLYS SURGEON WAS ABLE TO IMPACT THE 8 MM POLY. SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7008698 ↗MalfunctionNov 8, 2017Malposition of Device
IT WAS REPORTED THAT THE 8MM POLY INSERT DID NOT PROPERLY SIT IN THE TRAY DURING SURGERY. THE 6MM POLY INSERT WAS IMPLANTED TO COMPLETE THE CASE.
Patient problems: No Code Available
MAUDE report 7008694 ↗InjurySep 13, 2017Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAS EXTRANEOUS BONE CEMENT IN THE JOINT. A PROCEDURE IS PLANNED TO REMOVE THE EXTRANEOUS BONE CEMENT ARTHROSCOPICALLY. A PROCEDURE TO OPEN THE KNEE AND REMOVE THE POLY INSERT TO EXTRICATE THE CEMENT MAY BE REQUIRED.
Patient problems: No Information
MAUDE report 6860991 ↗InjuryJun 21, 2017Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.
Patient problems: Unspecified Infection
MAUDE report 6656626 ↗InjuryMay 23, 2017Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT IS HAVING RECURRING PAIN IN THE KNEE. THE SURGEON BELIEVES THE PATIENT MAY HAVE A LATERAL MENISCUS TEAR. A PROCEDURE IS PLANNED TO PERFORM A DIAGNOSTIC SCOPE. POLY INSERT REPLACEMENT MAY BE REQUIRED
Patient problems: Pain
MAUDE report 6583929 ↗
Other Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 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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