MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL HIP G2; HIP REPLACEMENT SYSTEM

Catalog Number HAA-050-D001

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the ijigs with serial number (b)(4) were incorrectly packaged with kit (b)(4).This issue was discovered by the surgeon during the procedure.The surgeon proceeded to freehand the resections according to the iview and successfully completed the case.Kit (b)(4) had not been shipped out to the customer and was still within conformis' manufacturing facility.The kit was opened and was found to have the ijigs for (b)(4).A capa has been initiated to track and record the corrective and preventive actions associated with this failure.

Event Description

It was reported that the ijigs with serial number (b)(4) were incorrectly packaged with kit (b)(4).This issue was discovered by the surgeon during the procedure.The surgeon proceeded to freehand the resections according to the iview and successfully completed the case.

• Brand Name: ITOTAL HIP G2
• Type of Device: HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica, ma
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington, ma
• Manufacturer Contact: emmanuel nyakako ; 600 technology park drive; billerica, ma ; 3459164
• MDR Report Key: 10125382
• MDR Text Key: 194300838
• Report Number: 3004153240-2020-00101
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M572HAA050D001021
• UDI-Public: +M572HAA050D001021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192198
• 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: 06/05/2020

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
• Device Catalogue Number: HAA-050-D001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• 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): Required Intervention
• Patient Age: 69 YR