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

Model Number TCR101111201

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2022

Event Type  Injury  

Event Description

It was reported that the cs inserts and trials interfered with the tibial tray and could not be inserted.There was not enough clearance with the central rail.This was an issue on all trials and on all inserts opened (6 and 7mm).Ultimately, dr.(b)(6) had to manually remove the interfering material on the 6mm cs insert to get it to fit with the tray so he could finish implantation.There was a major intraoperative delay as a result of this incident.

Manufacturer Narrative

It was reported that the cs inserts and trials interfered with the tibial tray and could not be inserted.There was not enough clearance with the central rail.This was an issue on all trials and on all inserts opened (6 and 7mm).Ultimately, dr.(b)(6) had to manually remove the interfering material on the 6mm cs insert to get it to fit with the tray so he could finish implantation.There was a major intraoperative delay as a result of this incident.The device dhr was reviewed and the device was manufactured to specification.All sterilisation requirements were met.

• 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: 13501855
• MDR Text Key: 285406877
• Report Number: 3004153240-2022-00018
• 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: K210809
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• 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
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• 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; Hospitalization
• Patient Age: 66 YR