MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL CR-IPOLY; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number TCR1111111

Device Problems Patient-Device Incompatibility (2682); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Failure of Implant (1924)

Event Date 04/21/2021

Event Type  Injury  

Event Description

Conformis itotal cr-ipoly knee implant has failed after a total knee replacement left side.The device was custom made for patient but is to large.Either wrong knee was inserted or knee manufactured improperly.Patient is having a total revision after 18 months from prior surgery.I have reached out to conformis to notify them of failure and they will not communicate with me.(b)(6) found conformis knee to be swollen, unstable, out of alignment and loose.Total revision required.

• Brand Name: ITOTAL CR-IPOLY
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): CONFORMIS, INC.
• MDR Report Key: 16086075
• MDR Text Key: 306654221
• Report Number: MW5114120
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TCR1111111
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White