MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM; HIP COMPONENT

Model Number	PHA00240
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, broken femoral neck and pseudo tumor.

• Brand Name: PROFEMUR® Z STEM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9717374
• Report Number: 3010536692-2020-00121
• Device Sequence Number: 3320540
• Product Code: LPH
• UDI-Device Identifier: M684PHA002401
• UDI-Public: M684PHA002401
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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: PHA00240
• Device Catalogue Number: PHA00240
• Device Lot Number: W03314587
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 02/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR