MAUDE Adverse Event Report: CONFORMIS INC ITOTAL CR; KNEE REOLACEMENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/05/2023

Event Type  Injury  

Event Description

This patient has an infection.Fluid was drawn from the knee and cultured displaying signs of infection.New surgery date to replace tibial inserts: (b)(6) 2023.

• Brand Name: ITOTAL CR
• Type of Device: KNEE REOLACEMENT
• Manufacturer (Section D): CONFORMIS INC; 600 technology park drive,; fourth floor; billerica 01821
• Manufacturer (Section G): CONFORMIS INC; 600 technology park drive; fourth floor; billerica 01821
• Manufacturer Contact: elizabeth haines ; 600 technology park drive; fourth floor; billerica, MA 01821 ; 9785696862
• MDR Report Key: 16298809
• MDR Text Key: 308790867
• Report Number: 3004153240-2023-00006
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213389
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 59 YR
• Patient Sex: Male