MAUDE Adverse Event Report: CONFORMIS, INC ITOTAL PS KRS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problems No Apparent Adverse Event (3189); Inaccurate Information (4051)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2023

Event Type  Injury  

Event Description

Wrong keel and stem drill size on the iview, to the size if jigs sent to surgery.

Manufacturer Narrative

During the tib layout design process in cad, the solid works part has configurations for all sizes in the feature tree.After determining which size is most appropriate per wi-0913-79 al, the tib layout designer is supposed to go to the configurations and delete the non-applicable size configurations.This case ended up being a size medium, so the tib layout designer was supposed to delete the small and large configurations from the part.This was then missed by the reviewer, and it caused the automation to populate the wrong size on the iview.Per idealmed rep: surgery was delayed more than 15 minutes.The surgery was able to be completed.We worked together and got the size 12 step drill and keel size of 12 with the jigs set at 12 to complete the surgery.

• Brand Name: ITOTAL PS KRS
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 18236823
• MDR Text Key: 329359587
• Report Number: 3004153240-2023-00039
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161668
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2023
• 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: 77 YR