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

Model Number	HBS033000001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient's greater trochanter was cracked during a total hip arthroplasty.The surgery was completed successfully.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the patient's greater trochanter was cracked during a total hip arthroplasty.The surgery was completed successfully.

• Brand Name: ITOTAL HIP G2
• Common Device Name: HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica, ma
• MDR Report Key: 9935391
• Report Number: 3004153240-2020-00084
• Device Sequence Number: 10937976
• Product Code: LPH
• UDI-Device Identifier: M572HBS0330000011
• UDI-Public: +M572HBS0330000011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: HBS033000001
• Device Catalogue Number: HBS-033-0011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR