MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR FEMORAL NECK; HIP COMPONENT

Model Number	PHA01224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/02/2019
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 patient reports that while walking he suddenly felt a sharp pain in the area of the left hip and fell down.Basg ref.: (b)(4).

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9583399
• Report Number: 3010536692-2020-00033
• Device Sequence Number: 18914178
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012241
• UDI-Public: M684PHA012241
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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: PHA01224
• Device Catalogue Number: PHA01224
• Device Lot Number: V02143966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 106