MAUDE Adverse Event Report: CONFORMIS INC. IDENTITY IMPRINT CR; KNEE REPLACEMENT

Lot Number 0522142

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 04/07/2023

Event Type  Injury  

Event Description

The surgeon did a revision surgery on (b)(6) 2023 to replace the polys.As the patient experienced infection.The original surgery date was (b)(6) 2023.

• Brand Name: IDENTITY IMPRINT CR
• Type of Device: KNEE REPLACEMENT
• Manufacturer (Section D): CONFORMIS INC.; 600 technology park drive; fourth floor; billerica, ma MA 01821
• Manufacturer (Section G): CONFORMIS INC; 600 research dr.; wilmington, ma MA 01887
• Manufacturer Contact: terrance wong ; 600 technology park drive; fourth floor; billerica, MA 01821
• MDR Report Key: 17661282
• MDR Text Key: 322388925
• Report Number: 3004153240-2023-00026
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221404
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 0522142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• 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 Sex: Female