MAUDE Adverse Event Report: CONFORMIS INC CONFORMIS ITOTAL IDENTITY CR; TOTAL KNEE REPLACEMENT SYSTEM TKR

Model Number TCR-101-1112-010101

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/10/2022

Event Type  Injury  

Event Description

It was reported replacement poly inserts (8mm-12mm) 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.

Manufacturer Narrative

The sterilization date indicated this item was eo done on load (b)(4) done on (b)(6) 2021.There were no issues.There are no ncmrs for any other aspect of this device.It was reported that the patient developed an infection after the primary surgery.There have been no other reports of procedural or post-operative complications for this patient.Infection is a known complication of joint replacement surgery.Cause of infection cannot be conclusively determined with available information.

• Brand Name: CONFORMIS ITOTAL IDENTITY CR
• Type of Device: TOTAL KNEE REPLACEMENT SYSTEM TKR
• Manufacturer (Section D): CONFORMIS INC; 600 technology park drive; billerica MA 01821
• Manufacturer Contact: elizabeth haines ; 600 technology park drive; billerica, MA 01821 ; 9786596862
• MDR Report Key: 16133877
• MDR Text Key: 307037636
• Report Number: 3004153240-2023-00001
• Device Sequence Number: 1
• Product Code: JWH
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TCR-101-1112-010101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2021
• 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): Other
• Patient Age: 47 YR