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

Model Number	TPS000D00201
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the f4 jigs for two imprint cases were swapped - a size 5 right with a size 3 left.This error was discovered intra-operatively for sn (b)(4) (size 5 r case; size 3 l shipped).The surgeon did not realise they had the incorrect f4 until completing the resections.As a result, the resections had to be manually corrected to fit the implant.There was a major delay of more than 20 minutes as a result of this issue.The device dhr was reviewed and the device was manufactured to specification.All sterilisation requirements were met.
Event or Problem Description
It was reported that the f4 jigs for two imprint cases were swapped - a size 5 right with a size 3 left.This error was discovered intra-operatively for sn (b)(4) (size 5 r case; size 3 l shipped).The surgeon did not realise they had the incorrect f4 until completing the resections.As a result, the resections had to be manually corrected to fit the implant.There was a major delay of more than 20 minutes as a result of this issue.

• Brand Name: ITOTAL IDENTITY IMPRINT PS
• Common Device Name: 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: 14115914
• Report Number: 3004153240-2022-00059
• Device Sequence Number: 4249997
• Product Code: JWH
• UDI-Device Identifier: M572TPS000D002011
• UDI-Public: M572TPS000D002011
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown