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

Model Number	PHA03146
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, neck fracture and proximally fractured stem in intramedullary situation with endosteal support.Not revised components: 38ha5258 conserve plus ha cup.Update received on 12/03/2019.Patient suffered high levels of cobalt and chromium.

• Brand Name: PROFEMUR® EHS HIP STEM STD
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9460955
• Report Number: 3010536692-2019-01171
• Device Sequence Number: 3078655
• Product Code: LPH
• UDI-Device Identifier: M684PHA031461
• UDI-Public: M684PHA031461
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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: PHA03146
• Device Catalogue Number: PHA03146
• Device Lot Number: 0611360476
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR