MAUDE Adverse Event Report: CONFORMIS, INC IDUO PKRS; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/17/2023

Event Type  Injury  

Manufacturer Narrative

On 10/19/2023, the sn was entered into the ncmr database with no returns.This indicates the device was designed and manufactured to specifications.(b)(6).The device was vhp sterilized and on 03/03/2023 released with no associated non-conformances.All sterilization requirements were met.Infection is a known complication of joint replacement surgery.Based on the available information, the cause of infection cannot be conclusively be determined to be related to the device.

Event Description

On 10/17/2023, the sales rep ordered replacement poly inserts for the patient for an infection, and the need for a synovectomy/exploration on the affected joint where poly inserts will be exchanged during the procedure.The primary surgery was on (b)(6) 2023, the new surgery is scheduled for on (b)(6) 2023.

• Brand Name: IDUO PKRS
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): CONFORMIS, INC; 600 technology park drive; fourth floor; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC; 600 research dr.; wilmington MA 01887
• Manufacturer Contact: terrance wong ; 600 technology park drive; fourth floor; billerica, MA 01821
• MDR Report Key: 18046266
• MDR Text Key: 327025275
• Report Number: 3004153240-2023-00035
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093513
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2023
• 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: 50 YR