MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY IMPRINT PS; TOTAL KNEE REPAIR SYSTEM

Model Number TPS000D00201

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the incorrect standard jigs were shipped to the surgeon.This was discovered after the surgeon's distal femur and proximal tibia resections were made with the patient specific jigs.The surgeon swapped to a depuy knee to be able to complete the surgery.There was a major delay of more than 20 minutes as a result of this incident.The device dhr was reviewed and the device was manufactured to specification.All sterilisation requirements were met.

Event Description

It was reported that the incorrect standard jigs were shipped to the surgeon.This was discovered after the surgeon's distal femur and proximal tibia resections were made with the patient specific jigs.The surgeon swapped to a depuy knee to be able to complete the surgery.There was a major delay of more than 20 minutes as a result of this incident.

• Brand Name: ITOTAL IDENTITY IMPRINT PS
• Type of Device: TOTAL KNEE REPAIR SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: kara johnson ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 13807400
• MDR Text Key: 287431149
• Report Number: 3004153240-2022-00041
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M572TPS000D002011
• UDI-Public: M572TPS000D002011
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPS000D00201
• Device Catalogue Number: TPS-000-D002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR