MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY CR; TOTAL KNEE REPAIR SYSTEM

Model Number TCR101111201

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); Pain (1994)

Event Date 01/03/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is midflexion instability and development of patellofemoral arthritis and pain.Primary surgery occurred on (b)(6) 2021.Revision surgery date is unknown.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.

Event Description

It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is midflexion instability and development of patellofemoral arthritis and pain.Primary surgery occurred on (b)(6) 2021.Revision surgery date is unknown.

• Brand Name: ITOTAL IDENTITY CR
• Type of Device: TOTAL KNEE REPAIR SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: kara johnson ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 13429525
• MDR Text Key: 284961516
• Report Number: 3004153240-2022-00012
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M572TCR1011112011
• UDI-Public: M572TCR1011112011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TCR101111201
• Device Catalogue Number: TCR-101-1112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR