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

Catalog Number HAA-050-D001

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the trial neck broke during surgery.There was no harm to the patient and the case was completed successfully.Review of the device history record indicates that the device was manufactured to specification.Minor design changes have been made to strengthen the trial neck's broach connection feature.Results from finite element analysis showing reduced maximum stress provide evidence that the minor design changes improved bending strength.

Event Description

It was reported that the trial neck broke during surgery.There was no harm to the patient and the case was completed successfully.

• 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: 10125421
• MDR Text Key: 194474619
• Report Number: 3004153240-2020-00105
• 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?: No
• Is this a Product Problem Report?: Yes
• 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: 02/27/2020
• 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 Age: 66 YR