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

Model Number HCC032B05601

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the surgeon noticed that the cup had shifted right before closing up the patient.It was noted that the surgeon doesn't use screws for most cases.The surgeon had to remove the liner from the cup and reposition it using screws to successfully complete the surgery, but the issue resulted in a 45 minute delay in the procedure.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the surgeon noticed that the cup had shifted right before closing up the patient.It was noted that the surgeon doesn't use screws for most cases.The surgeon had to remove the liner from the cup and reposition it using screws to successfully complete the surgery, but the issue resulted in a 45 minute delay in the procedure.

• 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: 10393037
• MDR Text Key: 202450035
• Report Number: 3004153240-2020-00141
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M572HCC032B056011
• UDI-Public: +M572HCC032B056011
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HCC032B05601
• Device Catalogue Number: HCC-032-B056
• Device Lot Number: 727127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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: 34 YR